PENTAX
Report
- Report Number
- 2518897-2014-00012
- Event Type
- Death
- Date Received
- December 16, 2014
- Date of Event
- January 1, 2014
- Report Date
- November 17, 2014
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FDT
- PMA / PMN Number
- K092710
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
NA.
(B)(4). PRIOR TO BEING GRANTED THE REPORTING EXEMPTION IN AUGUST 2015, PENTAX MEDICAL WAS SUBMITTING REPORTS ON PAPER USING THE IMPORTER REPORT NUMBER AND COMPLETING ALL REQUIRED SECTIONS OF THE 3500A FORM. AFTER THE REPORTING EXEMPTION WAS GRANTED, PENTAX MEDICAL CONTACTED THE EXEMPTIONS COORDINATOR FROM THE U.S. FOOD AND DRUG ADMINISTRATION, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, OFFICE OF SURVEILLANCE & BIOMETRICS, DIVISION OF POSTMARKET SURVEILLANCE, MDR POLICY BRANCH, IN REGARDS TO SUBMITTING SUPPLEMENTAL REPORTS WHERE THE INITIAL REPORT FILED BY AN IMPORTER WAS SUBMITTED ON PAPER. ON 09/15/2015, A RESPONSE WAS RECEIVED FROM THE EXEMPTIONS COORDINATOR STATING PENTAX MEDICAL MAY CONTINUE TO SUBMIT SUPPLEMENTAL REPORTS ON PAPER USING THE SAME IMPORTER REGISTRATION NUMBER FROM THE ORIGINAL REPORT. PENTAX MEDICAL ADHERED TO THIS PROCESS. AFTER BEING NOTIFIED BY THE DIVISION DIRECTOR OF THE DIVISION OF POSTMARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS, CENTER FOR DEVICE AND RADIOLOGICAL HEALTH, OF REPORTS NOT ACCEPTED DUE TO THE ELECTRONIC MEDICAL DEVICE REPORTING REQUIREMENT, PENTAX MEDICAL SPOKE TO THE EXEMPTIONS COORDINATOR VIA PHONE ON 05/20/2016, WHO STATED, GOING FORWARD, WHEN SUBMITTING SUPPLEMENTAL REPORTS WHERE THE INITIAL REPORT FILED BY THE IMPORTER WAS SUBMITTED ON PAPER, ESUBMITTER SHOULD BE USED AND THE IMPORTER REPORT # SHOULD BE ENTERED. SINCE DATA WILL NOT BE ALLOWED TO BE ENTERED IN ALL OF SECTION G AND SECTION H1 THROUGH H9, ANY DATA FOR THESE SECTIONS SHOULD BE ENTERED IN SECTION H10.
(B)(4). THE FOLLOWING PARAGRAPH WAS REMOVED "BASED ON THE INFORMATION RECEIVED FROM THE COMPLAINANT AND THE INVESTIGATION COMPLETED BY PENTAX MEDICAL ON (B)(6) 2016, IT IS REASONABLE TO SUGGEST USER ERROR AS THE ROOT CAUSE OF THE EVENT, DUE TO THE FACILITY NOT PROPERLY PERFORMING MANUAL CLEANING OF THE DUODENOSCOPE". FOLLOW UP#3. PRIOR TO BEING GRANTED THE REPORTING EXEMPTION IN (B)(6) 2015, PENTAX MEDICAL WAS SUBMITTING REPORTS ON PAPER USING THE IMPORTER REPORT NUMBER AND COMPLETING ALL REQUIRED SECTIONS OF THE 3500A FORM. AFTER THE REPORTING EXEMPTION WAS GRANTED, PENTAX MEDICAL CONTACTED THE EXEMPTIONS COORDINATOR FROM THE U.S. FOOD AND DRUG ADMINISTRATION, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, OFFICE OF SURVEILLANCE & BIOMETRICS, DIVISION OF POSTMARKET SURVEILLANCE, MDR POLICY BRANCH, IN REGARDS TO SUBMITTING SUPPLEMENTAL REPORTS WHERE THE INITIAL REPORT FILED BY AN IMPORTER WAS SUBMITTED ON PAPER. ON (B)(6) 2015, A RESPONSE WAS RECEIVED FROM THE EXEMPTIONS COORDINATOR STATING PENTAX MEDICAL MAY CONTINUE TO SUBMIT SUPPLEMENTAL REPORTS ON PAPER USING THE SAME IMPORTER REGISTRATION NUMBER FROM THE ORIGINAL REPORT. PENTAX MEDICAL ADHERED TO THIS PROCESS. AFTER BEING NOTIFIED BY THE DIVISION DIRECTOR OF THE DIVISION OF POSTMARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS, CENTER FOR DEVICE AND RADIOLOGICAL HEALTH, OF REPORTS NOT ACCEPTED DUE TO THE ELECTRONIC MEDICAL DEVICE REPORTING REQUIREMENT, PENTAX MEDICAL SPOKE TO THE EXEMPTIONS COORDINATOR VIA PHONE ON (B)(6) 2016, WHO STATED, GOING FORWARD, WHEN SUBMITTING SUPPLEMENTAL REPORTS WHERE THE INITIAL REPORT FILED BY THE IMPORTER WAS SUBMITTED ON PAPER, ESUBMITTER SHOULD BE USED AND THE IMPORTER REPORT # SHOULD BE ENTERED. SINCE DATA WILL NOT BE ALLOWED TO BE ENTERED IN ALL OF SECTIONS ANY DATA FOR THESE SECTIONS SHOULD BE ENTERED IN .
THE DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL ON 12/02/2014 FOR EVALUATION. DUE TO THE NATURE OF THE EVENT, ALL PERSONNEL WERE TRAINED ON THE PROTOCOL TO BE FOLLOWED BEFORE THE START OF THE INSPECTION AND DISASSEMBLY. THE DUODENOSCOPE WAS REPROCESSED ACCORDING TO PROCEDURE AND INSPECTED. THE PENTAX SERVICE INSPECTION FINDINGS INCLUDED THE FOLLOWING: -UP/DOWN CONTROL KNOB/LEVER CRACKED; -FLUID INVASION NOT OBSERVED IN CONTROL BODY; -FLUID INVASION NOT OBSERVED IN PVE CONNECTOR; -LEAK AT UP/DOWN CONTROL KNOB/LEVER. THE DUODENOSCOPE WAS THEN TRANSPORTED TO A FUME HOOD, WHERE ALL DISASSEMBLY PROCESSES TOOK PLACE. UPON DISASSEMBLY OF THE DUODENOSCOPE, THE FOLLOWING WERE PERFORMED: -THE INTERNAL CHANNEL WAS INSPECTED, IN WHICH NO SIGN OF DEBRIS WAS FOUND BEFORE OR AFTER THE CHANNEL WAS CUT OPEN LENGTHWISE. -DISTAL END SIDE (DISTAL CAP) AND THE ELEVATOR MECHANISM WERE INSPECTED. A VERY MILD SIGN OF GOUGING AND POSSIBLE SHREDDING OF THE MATERIAL AT THE TOP SECTION OF THE DISTAL CAP WAS VISUALIZED. NO OTHER VISIBLE SIGNS OF DEBRIS ANYWHERE AROUND THE DISTAL CAP AREA. HOWEVER, DEBRIS WAS VISUALIZED IN THE DISTAL CAP. AS THE ELEVATOR MECHANISM SECTION WAS BEING REMOVED, SEVERAL SIGNS OF WHITE STAINS WERE VISUALIZED ON BOTH SIDES OF THE DISTAL BODY WHICH HOUSES THE ELEVATOR BODY. DURING DISASSEMBLY OF THE DISTAL BODY SIDE COVER FOR THE DEFLECTOR SIDE, SEVERAL BROWNISH LOOKING DEBRIS/DUST PARTICLES WERE VISUALIZED IN THE SECTION WHERE THE DEFLECTOR BODY LINK IS INSTALLED. WHEN THE DEFLECTOR BODY LINK (ELEVATOR PISTON WITH TWO O-RINGS) WAS REMOVED AND SEPARATED FROM THE DISTAL BODY, BROWNISH/RUST LOOKING DEBRIS WAS VISUALIZED AT THE END OF THE DEFLECTOR BODY LINK. THE SAME BROWNISH/RUST LOOKING DEBRIS WAS VISUALIZED AT THE RECESS SECTION OF THE DISTAL BODY. THE DEFLECTOR BODY LINK O-RINGS WERE INTACT AND HAD NO SIGNS OF DEBRIS. THE INSPECTORS PAID SPECIAL ATTENTION FOR ANY COMPROMISED COMPONENTS DURING THE DISASSEMBLY PROCESS AND NONE WERE FOUND. THE DISASSEMBLED PARTS WERE SHIPPED TO (B)(6) ON (B)(6) 2015 TO PARTAKE IN A STUDY. A DEVICE HISTORY REVIEW WAS PERFORMED ON 12/05/2014 CONFIRMING THE VIDEO DUODENOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. PENTAX MEDICAL CONTACTED THE FACILITY ON (B)(6) 2015 AND (B)(6) 2015 FOR ADDITIONAL INFORMATION ON THE FACILITY'S ROOT CAUSE ANALYSIS, REPROCESSING AGENTS (I.E. DETERGENTS (ENZYMATIC AND NON-ENZYMATIC), HIGH LEVEL DISINFECTANTS, AND AUTOMATED ENDOSCOPE REPROCESSORS), AND REPROCESSING TECHNICIAN TRAINING. A RESPONSE WAS RECEIVED FROM THE FACILITY ON (B)(6) 2015 STATING THE FIRST PHASE OF THEIR ROOT CAUSE ANALYSIS PROVIDED SOME GENERAL BUT IMPORTANT OBSERVATIONS. IT SHOWED THAT EXPOSURE TO A CERTAIN DUODENOSCOPE WAS ASSOCIATED WITH FUTURE INFECTION WITH SPECIFIC STRAINS OF E.COLI. THE FACILITY STATED THEY WERE UNABLE TO DETERMINE WHERE ON THE DUODENOSCOPE THE NIDUS FOR BACTERIA MIGHT LAY OR THE SPECIFIC CAUSE OF THE TRANSMISSION. IN ADDITION, NO DEFECT IN THE DUODENOSCOPE CONSTRUCTION AND FUNCTION OR BREAK IN THE DUODENOSCOPE REPROCESSING WAS IDENTIFIED. THE FACILITY ALSO STATED THEY ARE DESIGNING A HEIGHTENED MONITORING SYSTEM AND PERHAPS FUTURE OBSERVATIONS WILL ALLOW MORE SPECIFIC DEDUCTIONS. NO INFORMATION WAS RECEIVED FROM THE FACILITY IN REGARDS TO WHAT DETERGENTS (ENZYMATIC AND NON-ENZYMATIC), AND HIGH LEVEL DISINFECTANTS ARE USED DURING REPROCESSING OF THE DUODENOSCOPE. INFORMATION REGARDING AUTOMATED ENDOSCOPE REPROCESSORS WAS RECEIVED. THE FACILITY DID STATE THAT THEIR TECHNICIANS ARE TRAINED AT THE BEGINNING OF THEIR EMPLOYMENT, UPDATED AT LEAST YEARLY BY (B)(6) HOSPITAL EXPERTS, PENTAX AND OTHER MANUFACTURES' REPRESENTATIVES AND THEIR PERFORMANCE IS REGULARLY OBSERVED BY ONSITE EXPERT SUPERVISORS. PENTAX MEDICAL CONTACTED THE FACILITY ON (B)(6) 2015 AND (B)(6) 2015 IN ORDER TO RECEIVE ADDITIONAL INFORMATION/CLARIFICATION ON THE FACILITY'S ROOT CAUSE ANALYSIS, WHICH BRUSHES ARE USED TO CLEAN THE CYLINDERS OF ENDOSCOPES, AND WHICH DETERGENTS (ENZYMATIC AND NON-ENZYMATIC) AND HIGH LEVEL DISINFECTANTS ARE USED DURING REPROCESSING OF THE ENDOSCOPES. NO ADDITIONAL INFORMATION/CLARIFICATION WAS RECEIVED. PENTAX MEDICAL CONTACTED THE FACILITY ON (B)(6) 2015, (B)(6) 2015 AND (B)(6) 2015 TO INQUIRE IF THE REPORTED DEATH WAS A RESULT OF THE E.COLI BACTEREMIAS, AND TO RETRIEVE ALL OTHER PENDING INFORMATION. NO FURTHER INFORMATION WAS PROVIDED FROM THE FACILITY IN REGARDS TO THIS EVENT. ON (B)(6) 2015 INFORMATION WAS RECEIVED FROM THE FACILITY WHICH STATED THE FACILITY BEGAN TESTING DUODENOSCOPES USING THE HEALTH MARK INDUSTRIES CHANNEL CHECK (3-IN-1 RESIDUAL SOIL TEST FOR LUMENED DEVICES) ON (B)(6) 2015. THE FACILITY STATED A RESIDUAL SOIL TEST, WHICH TESTS FOR THE PRESENCE OF CARBOHYDRATES, PROTEIN AND BLOOD IS PERFORMED AFTER EACH WASHING/REPROCESSING OF A DUODENOSCOPE AND PRIOR TO BEING USED IN A PATIENT CARE SETTING, AS A RISK MITIGATION STEP. THE PENTAX REGIONAL SERVICE MANAGER VISITED THE FACILITY DURING (B)(6) 2015 TO OBSERVE THE REPROCESSING TECHNIQUE FOLLOWED AT THE FACILITY. DURING THE VISIT, THE SERVICE MANAGER LEARNED THAT ERCP SCOPES AT THIS FACILITY CAN BE IN USE FOR ONE TO FOUR HOURS DURING A PROCEDURE, AND EVEN THOUGH THEY ARE TAGGED SO THEY GET IMMEDIATE ATTENTION WHEN THEY ARE BROUGHT INTO THE REPROCESSING ROOM, THE BIO-LOAD HAS BEEN IN AND ON THE SCOPES LONG ENOUGH TO ADHERE TO THE CHANNEL WALLS OR ANY OTHER SURFACE OF THE DUODENOSCOPE. DURING THE OBSERVATION OF THE REPROCESSING TECHNIQUE, THE SERVICE MANAGER REALIZED THAT THE REPROCESSING TECHNICIANS WERE NOT USING THE PURGE FUNCTION BUTTON ON THE CUSTOM ULTRASONICS WASH SINKS. THE SERVICE MANAGER STATED THE PURGE FUNCTION, AS PART OF THE MANUAL ENDOSCOPE CLEANING PROCESS, ALLOWS WARM ENZYMATIC SOAP TO FLOW THROUGH ALL OF THE LUMENS (ESPECIALLY THE BIOPSY CHANNEL) OF THE ENDOSCOPES, AND PERFORMING THIS FUNCTION HAS A SIGNIFICANT OUTCOME TOWARD GETTING PATIENT DEBRIS CLEANED FROM THE CHANNEL. AFTER THIS OBSERVATION WAS BROUGHT TO THE FACILITY'S PROCESSING COORDINATOR'S ATTENTION, THE VENDOR FOR CUSTOM ULTRASONICS (AMERICAN DREAM UNLIMITED, LLC) WAS CONTACTED, CONFIRMED WITH THE PROCESSING COORDINATOR THAT THE PURGE FUNCTION MUST BE USED FOR REPROCESSING ALL ENDOSCOPES AND ENSURED THAT ALL SINK COMPONENTS WERE AT FULL CAPACITY AND IN WORKING ORDER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PROCESSING COORDINATOR ON (B)(6) 2015 STATING THE REPROCESSING TEAM IS TAKING EXTRA PRECAUTIONARY PROCESSING MEASURES WITH ALL DUODENOSCOPES AS THEY ARE NOW BEING PLACED IN THE STERIS MACHINE, IN ADDITION TO THE POST PROCEDURE PRE-CLEANING, THE MANUAL SINK CLEANING, THE AER CLEANING AND OPA HIGH LEVEL DISINFECTANT CYCLE. IN ADDITION, ALL REPROCESSING TECHNICIANS HAVE BEEN RE-TRAINED/EDUCATED TO ENSURE THE PURGE FUNCTION ON THE CUSTOM ULTRASONICS SINKS IS PERFORMED FOR EVERY ENDOSCOPE AS PART OF THE MANUAL ENDOSCOPE CLEANING PROCESS. ONCE ALL REPROCESSING TECHNICIANS WERE RE-TRAINED/EDUCATED TO ENSURE THE PURGE FUNCTION ON THE CUSTOM ULTRASONICS SINKS IS PERFORMED FOR EVERY ENDOSCOPE AS PART OF THE MANUAL ENDOSCOPE CLEANING PROCESS, NO FURTHER REPORTS OF INFECTION HAVE BEEN RECEIVED FROM THE FACILITY. IN ADDITION, AS A RISK MITIGATION STEP, THE FACILITY BEGAN TESTING DUODENOSCOPES USING THE HEALTH MARK INDUSTRIES CHANNEL CHECK AFTER EACH WASHING/REPROCESSING OF A DUODENOSCOPE AND PRIOR TO BEING USED IN A PATIENT CARE. BASED ON THE INFORMATION RECEIVED FROM THE COMPLAINANT AND THE INVESTIGATION COMPLETED BY PENTAX MEDICAL ON (B)(6) 2016, IT IS REASONABLE TO SUGGEST USER ERROR AS THE ROOT CAUSE OF THE EVENT, DUE TO THE FACILITY NOT PROPERLY PERFORMING MANUAL CLEANING OF THE DUODENOSCOPE. NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, THEREFORE, PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.
PENTAX MEDICAL CONTACTED THE INITIAL REPORTER VIA EMAIL ON 01/05/2015 AND 01/20/2015. RESPONSES WERE RECEIVED FROM THE FACILITY ON 01/23/2015 INDICATING 7 PATIENTS TESTED POSITIVE FOR A SINGLE STRAIN TYPE OF CEFTRIAXONE-RESISTANT E. COLI POST-ERCP PROCEDURE PERFORMED WITH VIDEO DUODENOSCOPE MODEL ED-3490TK/SERIAL (B)(4). STRAIN TYPES 5A-H ARE RELATED TO EACH OTHER. PATIENT (B)(6) MET THE CASE DEFINITION OF "DELAYED BACTEREMIA POST-ERCP" MEANING PATIENT HAD (+) BLOOD CULTURE POST-ERCP AFTER 72 HOURS BUT WITHIN 30 DAYS POST-PROCEDURE. THE FACILITY PROTOCOL FOR INFECTIONS THAT ARE PART OF THE HOSPITAL SURVEILLANCE PLAN, WHICH INCLUDES BACTEREMIAS, IS THAT THE DEPARTMENT LEADERSHIP AND THE PROVIDER ARE NOTIFIED OF THE INFECTION; ANY TRENDS IDENTIFIED AND A REVIEW OF THE INFECTION (ROOT CAUSE ANALYSIS) IS COMPLETED. THE GROUP OF PATIENTS UNDERGOING ERCP WAS BEING TREATED FOR A RANGE OF PANCREATIC AND BILIARY DISEASES; IT WOULD BE DIFFICULT TO DETERMINE SPECIFIC SIGNS AND SYMPTOMS OTHER THAN FEVER/CHILLS AND MALAISE THAT WOULD BE RELATED TO THE POST-PROCEDURE BACTEREMIAS. PATIENT WAS TREATED FOR BACTEREMIAS WITH APPROPRIATE ANTIBIOTICS. PATIENT WAS NOT RECALLED FOR FURTHER SCREENING AS THE MARKER FOR THIS OUTBREAK INVESTIGATION WAS A (+) BLOOD CULTURE FOR CEFTRIAXONE-RESISTANT E. COLI; ALL (+) BLOOD CULTURES ARE REVIEWED DAILY BY INFECTION PREVENTIONISTS. PENTAX MEDICAL CONTACTED THE INITIAL REPORTER VIA EMAIL ON 05/21/2015 IN REGARDS TO CURRENT PATIENT STATUS. A RESPONSE WAS RECEIVED FROM THE FACILITY ON 06/11/2015 INDICATING 4 PATIENTS HAD DIED, INCLUDING PATIENT ID (B)(6). A 30 DAY INITIAL MDR 2518897-2014-00012 WAS FILED ON 12/15/2014 WHICH INCLUDED INITIAL INFORMATION REGARDING THIS EVENT. FOLLOW UP#1 MDR 2518897-2014-00012 INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01/23/2015 AND 06/11/2015 REGARDING THE EVENT AND PATIENT ID (B)(6). INITIAL MDR 2518897-2015-00009 INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01/23/2015 IN REGARDS TO PATIENT ID (B)(6). INITIAL MDR 2518897-2015-00010 INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01/23/2015 AND 06/11/2015 ON PATIENT ID (B)(6). INITIAL MDR 2518897-2015-00011 INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01/23/2015 AND 06/11/2015 ON PATIENT ID (B)(6). INITIAL MDR 2518897-2015-00012 INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01/23/2015 IN REGARDS TO PATIENT ID (B)(6). INITIAL MDR 2518897-2015-00013 INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01/23/2015 IN REGARDS TO PATIENT ID (B)(6). INITIAL MDR 2518897-2015-00014 INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01/23/2015 AND 06/11/2015 ON PATIENT ID (B)(6). PENTAX MEDICAL CONTACTED THE INITIAL REPORTER VIA EMAIL ON 01/05/2015 AND 01/20/2015. RESPONSES WERE RECEIVED FROM THE FACILITY ON 01/23/2015 INDICATING THAT PATIENT ID (B)(6) TESTED POSITIVE FOR A SINGLE STRAIN TYPE OF CEFTRIAXONE-RESISTANT E. COLI POST-ERCP PROCEDURE PERFORMED WITH VIDEO DUODENOSCOPE MODEL ED-3490TK/SERIAL (B)(4). PENTAX MEDICAL CONTACTED THE INITIAL REPORTER VIA EMAIL ON 05/21/2015 IN REGARDS TO CURRENT PATIENT STATUS. A RESPONSE WAS RECEIVED FROM THE FACILITY ON 06/11/2015 INDICATING THAT PATIENT ID (B)(6) DIED ON (B)(6) 2014.
THE DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL ON (B)(6) 2014 FOR EVALUATION. DUE TO THE NATURE OF THE EVENT, ALL PERSONNEL WERE TRAINED ON THE PROTOCOL TO BE FOLLOWED BEFORE THE START OF THE INSPECTION AND DISASSEMBLY. THE DUODENOSCOPE WAS REPROCESSED ACCORDING TO PROCEDURE AND INSPECTED. THE PENTAX SERVICE INSPECTION FINDINGS INCLUDED THE FOLLOWING: UP/DOWN CONTROL KNOB/LEVER CRACKED. FLUID INVASION NOT OBSERVED IN CONTROL BODY. FLUID INVASION NOT OBSERVED IN PVE CONNECTOR. LEAK AT UP/DOWN CONTROL KNOB/LEVER. THE DUODENOSCOPE WAS THEN TRANSPORTED TO A FUME HOOD, WHERE ALL DISASSEMBLY PROCESSES TOOK PLACE. UPON DISASSEMBLY OF THE DUODENOSCOPE, THE FOLLOWING WERE PERFORMED: THE INTERNAL CHANNEL WAS INSPECTED, IN WHICH NO SIGN OF DEBRIS WAS FOUND BEFORE OR AFTER THE CHANNEL WAS CUT OPEN LENGTHWISE. DISTAL END SIDE (DISTAL CAP) AND THE ELEVATOR MECHANISM WERE INSPECTED. A VERY MILD SIGN OF GOUGING AND POSSIBLE SHREDDING OF THE MATERIAL AT THE TOP SECTION OF THE DISTAL CAP WAS VISUALIZED. NO OTHER VISIBLE SIGNS OF DEBRIS ANYWHERE AROUND THE DISTAL CAP AREA HOWEVER, DEBRIS WAS VISUALIZED IN THE DISTAL CAP. AS THE ELEVATOR MECHANISM SECTION WAS BEING REMOVED, SEVERAL SIGNS OF WHITE STAINS WERE VISUALIZED ON BOTH SIDES OF THE DISTAL BODY WHICH HOUSES THE ELEVATOR BODY. DURING DISASSEMBLY OF THE DISTAL BODY SIDE COVER FOR THE DEFLECTOR SIDE, SEVERAL BROWNISH LOOKING DEBRIS/DUST PARTICLES WERE VISUALIZED IN THE SECTION WHERE THE DEFLECTOR BODY LINK IS INSTALLED. WHEN THE DEFLECTOR BODY LINK (ELEVATOR PISTON WITH TWO O-RINGS) WAS REMOVED AND SEPARATED FROM THE DISTAL BODY, BROWNISH/RUST LOOKING DEBRIS WAS VISUALIZED AT THE END OF THE DEFLECTOR BODY LINK. THE SAME BROWNISH/RUST LOOKING DEBRIS WAS VISUALIZED AT THE RECESS SECTION OF THE DISTAL BODY. THE DEFLECTOR BODY LINK O-RINGS WERE INTACT AND HAD NO SIGNS OF DEBRIS. THE INSPECTORS PAID SPECIAL ATTENTION FOR ANY COMPROMISED COMPONENTS DURING THE DISASSEMBLY PROCESS AND NONE WERE FOUND. THE DISASSEMBLED PARTS WERE SHIPPED TO JAPAN ON (B)(6) 2015 TO PARTAKE IN A STUDY. A DEVICE HISTORY REVIEW WAS PERFORMED ON (B)(6) 2014 CONFIRMING THE VIDEO DUODENOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. PENTAX MEDICAL CONTACTED THE FACILITY ON (B)(6) 2015 FOR ADDITIONAL INFORMATION ON THE FACILITY'S ROOT CAUSE ANALYSIS, REPROCESSING AGENTS (I.E. DETERGENTS (ENZYMATIC AND NON-ENZYMATIC), HIGH LEVEL DISINFECTANTS, AND AUTOMATED ENDOSCOPE REPROCESSORS), AND REPROCESSING TECHNICIAN TRAINING. A RESPONSE WAS RECEIVED FROM THE FACILITY ON (B)(6) 2015 STATING THE FIRST PHASE OF THEIR ROOT CAUSE ANALYSIS PROVIDED SOME GENERAL BUT IMPORTANT OBSERVATIONS. IT SHOWED THAT EXPOSURE TO A CERTAIN DUODENOSCOPE WAS ASSOCIATED WITH FUTURE INFECTION WITH SPECIFIC STRAINS OF E.COLI. THE FACILITY STATED THEY WERE UNABLE TO DETERMINE WHERE ON THE DUODENOSCOPE THE NIDUS FOR BACTERIA MIGHT LAY OR THE SPECIFIC CAUSE OF THE TRANSMISSION. IN ADDITION, NO DEFECT IN THE DUODENOSCOPE CONSTRUCTION AND FUNCTION OR BREAK IN THE DUODENOSCOPE REPROCESSING WAS IDENTIFIED. THE FACILITY ALSO STATED THEY ARE DESIGNING A HEIGHTENED MONITORING SYSTEM AND PERHAPS FUTURE OBSERVATIONS WILL ALLOW MORE SPECIFIC DEDUCTIONS. NO INFORMATION WAS RECEIVED FROM THE FACILITY IN REGARDS TO WHAT DETERGENTS (ENZYMATIC AND NON-ENZYMATIC), AND HIGH LEVEL DISINFECTANTS ARE USED DURING REPROCESSING OF THE DUODENOSCOPE. INFORMATION REGARDING AUTOMATED ENDOSCOPE REPROCESSORS WAS RECEIVED. THE FACILITY DID STATE THAT THEIR TECHNICIANS ARE TRAINED AT THE BEGINNING OF THEIR EMPLOYMENT, UPDATED AT LEAST YEARLY BY MASSACHUSETTS GENERAL HOSPITAL EXPERTS, PENTAX AND OTHER MANUFACTURES' REPRESENTATIVES AND THEIR PERFORMANCE IS REGULARLY OBSERVED BY ONSITE EXPERT SUPERVISORS. PENTAX MEDICAL CONTACTED THE FACILITY ON (B)(6) 2015 IN ORDER TO RECEIVE ADDITIONAL INFORMATION/CLARIFICATION ON THE FACILITY'S ROOT CAUSE ANALYSIS, WHICH BRUSHES ARE USED TO CLEAN THE CYLINDERS OF ENDOSCOPES, AND WHICH DETERGENTS (ENZYMATIC AND NON-ENZYMATIC) AND HIGH LEVEL DISINFECTANTS ARE USED DURING REPROCESSING OF THE ENDOSCOPES. NO ADDITIONAL INFORMATION/CLARIFICATION WAS RECEIVED. PENTAX MEDICAL CONTACTED THE FACILITY ON (B)(6) 2015 TO INQUIRE IF THE REPORTED DEATH WAS A RESULT OF THE E.COLI BACTEREMIAS, AND TO RETRIEVE ALL OTHER PENDING INFORMATION. NO FURTHER INFORMATION WAS PROVIDED FROM THE FACILITY IN REGARDS TO THIS EVENT. ON (B)(6) 2015 INFORMATION WAS RECEIVED FROM THE FACILITY WHICH STATED THE FACILITY BEGAN TESTING DUODENOSCOPES USING THE HEALTH MARK INDUSTRIES CHANNEL CHECK (3-IN-1 RESIDUAL SOIL TEST FOR LUMENED DEVICES) ON (B)(6) 2015. THE FACILITY STATED A RESIDUAL SOIL TEST, WHICH TESTS FOR THE PRESENCE OF CARBOHYDRATES, PROTEIN AND BLOOD IS PERFORMED AFTER EACH WASHING/REPROCESSING OF A DUODENOSCOPE AND PRIOR TO BEING USED IN A PATIENT CARE SETTING, AS A RISK MITIGATION STEP. THE PENTAX REGIONAL SERVICE MANAGER VISITED THE FACILITY DURING (B)(6) 2015 TO OBSERVE THE REPROCESSING TECHNIQUE FOLLOWED AT THE FACILITY. DURING THE VISIT, THE SERVICE MANAGER LEARNED THAT ERCP SCOPES AT THIS FACILITY CAN BE IN USE FOR ONE TO FOUR HOURS DURING A PROCEDURE, AND EVEN THOUGH THEY ARE TAGGED SO THEY GET IMMEDIATE ATTENTION WHEN THEY ARE BROUGHT INTO THE REPROCESSING ROOM, THE BIO-LOAD HAS BEEN IN AND ON THE SCOPES LONG ENOUGH TO ADHERE TO THE CHANNEL WALLS OR ANY OTHER SURFACE OF THE DUODENOSCOPE. DURING THE OBSERVATION OF THE REPROCESSING TECHNIQUE, THE SERVICE MANAGER REALIZED THAT THE REPROCESSING TECHNICIANS WERE NOT USING THE PURGE FUNCTION BUTTON ON THE CUSTOM ULTRASONICS WASH SINKS. THE SERVICE MANAGER STATED THE PURGE FUNCTION, AS PART OF THE MANUAL ENDOSCOPE CLEANING PROCESS, ALLOWS WARM ENZYMATIC SOAP TO FLOW THROUGH ALL OF THE LUMENS (ESPECIALLY THE BIOPSY CHANNEL) OF THE ENDOSCOPES, AND PERFORMING THIS FUNCTION HAS A SIGNIFICANT OUTCOME TOWARD GETTING PATIENT DEBRIS CLEANED FROM THE CHANNEL. AFTER THIS OBSERVATION WAS BROUGHT TO THE FACILITY'S PROCESSING COORDINATOR'S ATTENTION, THE VENDOR FOR CUSTOM ULTRASONICS ((B)(4)) WAS CONTACTED, CONFIRMED WITH THE PROCESSING COORDINATOR THAT THE PURGE FUNCTION MUST BE USED FOR REPROCESSING ALL ENDOSCOPES AND ENSURED THAT ALL SINK COMPONENTS WERE AT FULL CAPACITY AND IN WORKING ORDER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PROCESSING COORDINATOR ON (B)(6) 2015 STATING THE REPROCESSING TEAM IS TAKING EXTRA PRECAUTIONARY PROCESSING MEASURES WITH ALL DUODENOSCOPES AS THEY ARE NOW BEING PLACED IN THE STERIS MACHINE, IN ADDITION TO THE POST PROCEDURE PRE-CLEANING, THE MANUAL SINK CLEANING, THE AER CLEANING AND OPA HIGH LEVEL DISINFECTANT CYCLE. IN ADDITION, ALL REPROCESSING TECHNICIANS HAVE BEEN RE-TRAINED/EDUCATED TO ENSURE THE PURGE FUNCTION ON THE CUSTOM ULTRASONICS SINKS IS PERFORMED FOR EVERY ENDOSCOPE AS PART OF THE MANUAL ENDOSCOPE CLEANING PROCESS. ONCE ALL REPROCESSING TECHNICIANS WERE RE-TRAINED/EDUCATED TO ENSURE THE PURGE FUNCTION ON THE CUSTOM ULTRASONICS SINKS IS PERFORMED FOR EVERY ENDOSCOPE AS PART OF THE MANUAL ENDOSCOPE CLEANING PROCESS, NO FURTHER REPORTS OF INFECTION HAVE BEEN RECEIVED FROM THE FACILITY. IN ADDITION, AS A RISK MITIGATION STEP, THE FACILITY BEGAN TESTING DUODENOSCOPES USING THE HEALTH MARK INDUSTRIES CHANNEL CHECK AFTER EACH WASHING/REPROCESSING OF A DUODENOSCOPE AND PRIOR TO BEING USED IN A PATIENT CARE. NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, THEREFORE, PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.
ON (B)(6) 2014, PENTAX MEDICAL RECEIVED A REPORT FROM (B)(6), DIRECTOR OF THE INFECTION CONTROL UNIT AT (B)(6) STATING THAT DUODENOSCOPE MODEL ED-63490TK/SN (B)(4) SHOWED AN INCREASED INCIDENCE IN POST-PROCEDURE DRUG-RESISTANT E. COLI BACTEREMIA. THE DUODENOSCOPE WAS ALSO ASSOCIATED WITH A SIGNIFICANTLY HIGHER PROPORTION OF INFECTIONS. THE DUODENOSCOPE WAS RETURNED TO PENTAX MEDICAL ON (B)(6) 2014 AND IS CURRENTLY UNDER EVALUATION. IN ORDER TO RECEIVE ADDITIONAL INFORMATION REGARDING THE EVENT, PENTAX MEDICAL CONTACTED THE INITIAL REPORTER VIA EMAIL ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 823600 | PENTAX | VIDEO DUODENOSCOPE | FDT | HOYA CORPORATION PENTAX TOKYO OFFICE | ED-3490TK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death| R |