EVIS EXERA II DUODENOVIDEOSCOPE
Report
- Report Number
- 8010047-2015-00996
- Event Type
- Injury
- Date Received
- November 2, 2015
- Report Date
- December 23, 2020
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORPORATION
- Product Code
- FDT
- PMA / PMN Number
- K080403
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE CHANGING "DEATH AND OTHER SERIOUS" TO "OTHER SERIOUS" AND CHANGING "DEATH" TO "SERIOUS INJURY", BECAUSE NO PATIENT DEATH IS REPORTED IN THE 28 PATIENTS AT THIS TIME. ADDITIONALLY ADDITIONAL INFORMATION IS BEING PROVIDED. OBV FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION ON THE REPROCESSING PRACTICE OF TJF-Q180V IN THE FACILITY AND THE DATE STARTING THE NEW REPROCESSING PRACTICE USING MAJ-1888, BUT WITH NO RESULT. THE FACILITY SAYS IT WILL NEED TWO MONTHS FOR PREPARING THE REPLY. ADDITIONALLY, OBV REQUESTED THE TJF-Q180V TO BE RETURNED TO OLYMPUS FOR EVALUATION, BUT THE FACILITY REFUSED IT. ACCORDING TO THE ABOVE SITUATION, THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AT THIS TIME. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME THESE REPORTS WILL BE SUPPLEMENTED. PLEASE CROSS-REFERENCE THE FOLLOWING REPORTS FOR THE OTHER 22 PATIENTS: 8010047-2015-00816, 8010047-2015-00817,8010047-2015-00818,8010047-2015-00819, 8010047-2015-00820, 8010047-2015-00821, 8010047-2015-00822,8010047-2015-00823,8010047-2015-00983, 8010047-2015-00984, 8010047-2015-00985, 8010047-2015-00986,8010047-2015-00987,8010047-2015-00988, 8010047-2015-00989, 8010047-2015-00990, 8010047-2015-00991,8010047-2015-00992,8010047-2015-00993, 8010047-2015-00994, 8010047-2015-00995 AND 8010047-2015-00997.
THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION ON INVESTIGATION OF TJF-Q180V SCOPES (SERIAL NUMBER OF (B)(4)) IN CONJUNCTION WITH DELFT UNIVERSITY. OLYMPUS (B)(4) RECEIVED A DRAFT OF A REPORT TITLED "STUDY OF OLYMPUS TJF-Q180V SCOPES AT (B)(4) REGARDING CONTAMINATION FOUND AFTER CLEANING AND DISINFECTION." OLYMPUS MEDICAL SYSTEMS CORP OBTAINED AN ENGLISH TRANSLATION OF THE DRAFT REPORT. THE REPORT MEDWATCH (B)(4) IS UNDER MFR REPORT# 8010047-2015-00816. APPEARANCE INSPECTION AND DISMANTLE INSPECTION OF THE SUBJECT DEVICES WERE PERFORMED, AND THE FOLLOWING FINDINGS ARE WRITTEN IN THE REPORT. VISUAL INSPECTION OF SERIAL NUMBER (B)(4) REVEALED THAT THERE WERE BROWN DEPOSITS ON THE FORCEPS ELEVATOR AND ON SEVERAL PARTS AROUND THE FORCEPS ELEVATOR. BROWN DEPOSIT BEHIND THE LIGHT SOURCE COVER GLASS WAS FOUND. THERE WERE SEVERAL SCRATCHES ON THE SUCTION/BIOPSY CHANNEL, AND WAS A LARGE DAMAGE ON THE DISTAL PART OF THE SUCTION/BIOPSY CHANNEL. THE GREEN THREAD TO TIE THE BENDING COVER ON THE DISTAL END SIDE WAS USED, WHICH IS DIFFERENT FROM BLACK THREAD THAT OLYMPUS USES. THE GLUE HAS NOT ADHERED TO THE THREAD PROPERLY AND IS PLACED ON TOP OF THE THREAD, NOT IN BETWEEN AND UNDERNEATH. THE GLUE SEEMS MORE BRITTLE THAN THE GLUE USED BY OLYMPUS. THERE IS HARDLY ANY LUBRICATING MATERIAL UNDERNEATH THE BENDING COVER. THERE WAS TOO LITTLE BLACK GLUE IN THE RIM AROUND THE SECTION OF THE HOUSING PART WHICH HOUSES THE FORCEPS ELEVATOR WIRE. SOME PARTS WERE EVEN OPEN. VISUAL INSPECTION OF SERIAL NUMBER (B)(4) REVEALED THAT THERE WERE SOME WHITE DEPOSITS ON THE FORCEPS ELEVATOR RECESS AND THE RIM OF THE FORCEPS ELEVATOR RECESS. BROWN DEPOSIT BEHIND THE COVER GLASSES OF THE LIGHT GUIDE LENS AND THE OBJECTIVE LENS WAS FOUND. THERE WERE SPACES BETWEEN THE FRAME OF THE TIP AND THE TIP COVER. THERE WERE SEVERAL SCRATCHES AND SOMETHING THAT LOOKS LIKE SMALL FIBERS IN THE SUCTION/BIOPSY CHANNEL. THE GREEN THREAD TO TIE THE BENDING COVER ON THE DISTAL END SIDE WAS USED, WHICH IS DIFFERENT FROM BLACK THREAD THAT OLYMPUS USES. THE GLUE HAS NOT ADHERED TO THE THREAD PROPERLY AND IS PLACED ON TOP OF THE THREAD, NOT IN BETWEEN AND UNDERNEATH. THE GLUE SEEMS MORE BRITTLE THAN THE GLUE USED BY OLYMPUS. THERE IS HARDLY ANY LUBRICATING MATERIAL UNDERNEATH THE BENDING COVER. THERE WAS TOO LITTLE BLACK GLUE IN THE RIM AROUND THE SECTION OF THE HOUSING PART WHICH HOUSES THE FORCEPS ELEVATOR WIRE. SOME PARTS WERE EVEN OPEN. THE BENDING COVER GLUE ON BOTH DISTAL END SIDE AND INSERTION TUBE SIDE ARE IRREGULAR AND TOO THICK AND A LOT OF DETACHMENT. THE EXTERIOR OF THE BIOPSY CHANNEL WAS DAMAGED. VISUAL INSPECTION REVEALED THAT BOTH SCOPES SHOWED AS FOLLOWS. BROWN DEPOSITS UNDER THE ARM COVER WERE FOUND. BROWN DEPOSITS WERE FOUND UNDER THE PLASTIC TIP COVER. BROWN DEPOSITS ARE FOUND: ON THE INTERNAL SIDE OF THE LEVER THAT MANIPULATES THE FORCEPS ELEVATOR. IN THE GROOVE IN THE LEVER THAT HOUSED THE O-RING, BOTH ON THE INTERNAL SIDE AND ON THE EXTERNAL SIDE. ON THE INTERNAL SIDE AND THE EXTERNAL SIDE OF THE O-RING; ON THE EXTERNAL SIDE OF THE LEVER, ESPECIALLY WHERE THE FORCEPS ELEVATOR WAS CONNECTED AROUND THE SHAFT; IN THE SHAFT OPENING OF THE FORCEPS ELEVATOR, WHERE THE LEVER WAS ATTACHED; ON THE SCREW THAT ATTACHES THE FORCEPS ELEVATOR TO THE LEVER SHAFT; ON SEVERAL AREAS OF THE FORCEPS ELEVATOR. THE BIOPSY CHANNEL WAS CONNECTED TO THE METAL PART OF THE DISTAL END WITHOUT THE THREAD INCONSISTENT WITH OLYMPUS STANDARD. THE MAINTENANCE MANAGEMENT SYSTEM OF THE (B)(4) SHOWED THAT THE SUBJECT SCOPES HAD CONSIDERABLE REPAIRS TO THE INSERTION TUBE, WHEREBY MANY PARTS WERE REPLACED BY THE THIRD PARTY. THE REPORT STATES THAT THE FINAL CONCLUSION REGARDING THE LOCATION AND REASON FOR THE PERSISTENCE OF THE MULTIDRUG RESISTANT KLEBSIELLA CANNOT BE PROVIDED DUE TO THE COINCIDENCE OF TWO COMPLICATING SITUATIONS: THE DISMANTLING STUDY WAS STARTED TOO LATE AFTER THE CONTAMINATIONS, SO THAT MULTIDRUG RESISTANT KLEBSIELLA WAS NO LONGER FOUND AND THE LOCATION OF THE PERSISTENCE COULD NOT BE DETERMINED. THERE IS A COMBINATION OF POTENTIAL CLEANING DEFICITS EXISTING AT THE (B)(4), REPAIRS CARRIED OUT BY RESCOPE NOT BEING IN ACCORDANCE WITH THE STANDARD, AND LIMITATIONS IN CLEANABILITY OF THE OLYMPUS SCOPES INHERENT TO THE DESIGN. IN THE REPORT RECOMMENDATIONS FOR POTENTIALLY PREVENTING INFECTION ARE WRITTEN AS FOLLOWS. IN THE EVENT OF CASES SIMILAR TO THOSE DESCRIBED IN THIS REPORT, START A THOROUGH STUDY OF THE SCOPE IN A TIMELY MANNER: IN THE MANNER AS DESCRIBED IN THIS REPORT, ONLY SOONER. MAKE SURE THE CLEANING AND DISINFECTION PROTOCOLS AT THE ENDOSCOPY DEPARTMENT ARE IN ORDER, KEEP THEM UP-TO-DATE AND ENSURE STRICT COMPLIANCE. FOLLOW THE MANUFACTURER'S INSTRUCTIONS AND/OR VALIDATE IN-HOUSE AMENDMENTS TO THE CLEANING PROCESS. VALIDATE THE WASHING AND DRYING PROTOCOLS. EVEN A WELL-CLEANED SCOPE CAN BECOME A BREEDING GROUND IF THE DRYING PROCESS IS INSUFFICIENT. IMPROVE THE DESIGN OF THE SCOPES BY ALLOWING MORE SPACE FOR DIFFICULT TO REACH PLACES INSIDE THE TIP AND THEREBY MAKING THEM MORE ACCESSIBLE FOR CLEANING. ALSO ENSURE RELIABLE, VALIDATED SEALS, INCLUDING THE DRIVE UNIT OF THE FORCEPS ELEVATOR, AND CARRY OUT PREVENTIVE CHECKS REGULARLY. ENSURE ADEQUATE CLEANING AND DRYING OF THE INTERIOR OF THE SCOPE AFTER LEAKAGE IN ORDER TO PREVENT MICROORGANISMS FROM MOVING FROM THE SCOPE TO THE EXTERIOR AFTER ANY POSSIBLE SUBSEQUENT LEAK OR SEAL FAILURE. FOR MAINTENANCE AND REPAIRS, ONLY USE ORIGINAL PARTS, PRESCRIBED BY THE MANUFACTURER OR VERIFIABLY VALIDATED PARTS, GLUES, MATERIALS AND WORKING METHODS. RESEARCH THE NECESSITY AND VALIDITY OF THE CE MARKING FOR SCOPES THAT HAVE BEEN REFURBISHED AS EXTENSIVELY AND NOT IN ACCORDANCE WITH OLYMPUS STANDARDS AS THE SUBJECT SCOPES. RESEARCH WHETHER THE REPAIRS CARRIED OUT BY RESCOPE NOT IN ACCORDANCE WITH OLYMPUS STANDARDS ARE INCIDENTAL OR STRUCTURAL IN NATURE. THERE WERE BROWN DEPOSITS ON THE LEVER THAT MANIPULATES THE FORCEPS ELEVATOR AND THE SECTION OF THE HOUSING PART. WITH REGARD TO RECOMMENDATION ON THE SEALS AS WELL AS FINDINGS OF DEPOSITS WRITTEN IN THE REPORT. OLYMPUS INSTRUCTS THE USERS IN THE IFU THAT THE TJF-Q180V SHOULD BE RETURNED TO OLYMPUS FOR ANNUAL INSPECTION TO CHECK FOR LEAK AND FOREIGN MATERIAL ATTACHING AROUND TO THE FORCEPS ELEVATOR MECHANISM. THE INSTRUCTION MANUAL STATES AS FOLLOWS; "6.3 ANNUAL INSPECTION SEND THE ENDOSCOPE TO OLYMPUS FOR INSPECTION OF THE FORCEPS ELEVATOR BY OLYMPUS ONCE A YEAR. CONTACT OLYMPUS FOR ANY QUESTIONS REGARDING ANNUAL INSPECTION." OLYMPUS WILL CONTINUE TO FOLLOW UP ON THIS REPORT.
(B)(4). ON DECEMBER 15TH, 2015, OLYMPUS (B)(4) VISITED THE USER FACILITY TO OBSERVE THE REPROCESSING PROCEDURE, AND FOUND THE FOLLOWING DEVIATIONS FROM THE STEPS ON THE REPROCESSING MANUAL; THE USER FACILITY DID NOT PERFORM WATER SUCTION AND AIR SUCTION IN PRE-CLEANING STEP. THE USER FACILITY WAS NOT USING THE AIR/WATER CHANNEL CLEANING ADAPTER (MH-948), AND WAS NOT FLUSHING THE AIR/WATER CHANNEL WITH WATER OR AIR FOR THE PRESCRIBED DURATION OF TIME. IN ADDITION, THE USER FACILITY WAS NOT USING THE SINGLE USE SOFT BRUSH (MAJ-1888) IN THE MANUAL-CLEANING STEP. THE USER FACILITY, ALSO, WAS NOT USING A SUCTION PUMP, THE SUCTION CLEANING ADAPTER (MH-856), INJECTION TUBE (MH-946), OR CHANNEL PLUG (MH-944), THUS WAS NOT FLUSHING THE AIR/WATER CHANNEL, INSTRUMENT CHANNEL, OR SUCTION CHANNEL WITH CLEANING DETERGENT, WATER OR AIR. THE USER FACILITY REQUESTED OLYMPUS TO INSPECT AND DISASSEMBLE THE TWO TJF-Q180V SCOPES (SERIAL NUMBER OF (B)(4)) WHEN INVESTIGATING THEM WITH (B)(6) UNIVERSITY ON DECEMBER 16TH, 2015. VISUAL INSPECTION REVEALED THAT BOTH ENDOSCOPES SHOWED PHYSICAL DAMAGES OF THE PLASTIC COVER AT THE DISTAL END. IN ADDITION, THE BIOPSY CHANNELS OF THE SCOPES HAD SEVERAL SCRATCHES AND UNKNOWN RESIDUES INSIDE. UNDER THE FORCEPS ELEVATOR OF SERIAL NUMBER (B)(4) OLYMPUS FOUND A WHITE MATERIAL. THE SCOPE OF SERIAL NUMBER (B)(4) HAD SOME GAPS BEHIND THE FORCEPS ELEVATOR, BETWEEN THE PLASTIC COVER AND THE METAL PARTS AT THE DISTAL END, INCONSISTENT WITH OLYMPUS STANDARDS. THE ENDOSCOPES WERE THEN DISASSEMBLED. A SECTION OF THE HOUSING PART WHICH HOUSES THE FORCEPS ELEVATOR WIRE WAS FIXED BY A MEANS DIFFERENT FROM OLYMPUS STANDARD (SOLDER RATHER THAN GLUE). THE SEALING AGENT WAS NOT PRESENT ON THE RUBBER PART AROUND THE INSTRUMENT CHANNEL PORT. THE OLYMPUS STANDARD IS TO APPLY SEALING AGENTS. THE INSERTION TUBE, THE CONTROL SECTION AND THE DISTAL END SHOWED SIGNS OF THIRD PARTY REPAIR. THE BIOPSY CHANNEL AND THE INSERTION TUBE WERE NOT REPAIR PARTS OF OLYMPUS. THE SCOPES AND ALL PARTS REMAINED WITH THE USER FACILITY REPRESENTATIVES. A FURTHER INVESTIGATION BY OLYMPUS IS THEREFORE NOT POSSIBLE. THERE IS NO REPAIR HISTORY FOR THESE TWO SCOPES IN THE OLYMPUS REPAIR CENTERS, MEANING THE SCOPES WERE NOT MAINTAINED OR REPAIRED BY OLYMPUS. THE INVESTIGATION SHOWED THAT THESE ENDOSCOPES WERE REPAIRED BY A THIRD PARTY COMPANY USING NON-OLYMPUS REPAIR PARTS. OLYMPUS DOES NOT HAVE KNOWLEDGE ABOUT THE DETAIL OF THE PARTS AND IS THEREFORE NOT ABLE TO COMMENT ON DURABILITY AND COMPATIBILITY WITH THE REPROCESSING PROCEDURE OF OLYMPUS. FURTHERMORE THE HOSPITAL DOES NOT EXACTLY FOLLOW THE REPROCESSING INSTRUCTIONS. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION ON INVESTIGATION OF TJF-Q180V SCOPES (SERIAL NUMBER OF (B)(4)). OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE PUBLISHED REPORT TITLED "STUDY OF OLYMPUS TJF-Q180V SCOPES AT UMC UTRECHT REGARDING CONTAMINATION FOUND AFTER CLEANING AND DISINFECTION" FROM (B)(6).
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REFLECT ADDITIONAL INFORMATION OLYMPUS OBTAINED. OLYMPUS OBTAINED ADDITIONAL INFORMATION ON THE 26 OUT OF 28 PATIENTS AND REPROCESSING PROTOCOL OF THE FACILITY. THE USER FACILITY AUDITED FOR DEVIATIONS IN THEIR REPROCESSING PROTOCOL FROM THE MANUFACTURER'S INSTRUCTIONS FOR USE FOR TJF-Q180V ON (B)(6) 2015. AS A RESULT, THE FOLLOWING DEVIATIONS WERE IDENTIFIED IN ADDITION TO THE DEVIATION NOTED DURING THE VISIT BY OLYMPUS (B)(4) ON (B)(6) 2015. LEAKAGE TEST STEPS: LEAKAGE TEST WAS NOT CARRIED OUT UNDER WATER; THE FORCEPS ELEVATOR WAS NOT MOVED; AIR/WATER CHANNEL WAS NOT FLUSHED WITH WATER; DURATION OF AIR FLUSHING OF AIR/WATER CHANNEL WAS NOT SPECIFIED IN THE USER FACILITY'S PROTOCOL. MANUAL-CLEANING STEPS: HOW AND WHAT TO BRUSH IN DETAIL WERE NOT DESCRIBED IN THE USER FACILITY'S BRUSHING PROTOCOL FOR THE FORCEPS ELEVATOR; HOW AND WHAT TO BRUSH IN DETAIL WERE NOT DESCRIBED IN THE USER FACILITY'S BRUSHING PROTOCOL FOR THE INSTRUMENT CHANNEL PORT; FLUSHING THE CLEANING DETERGENT ON THE FORCEPS ELEVATOR RECESS WAS PERFORMED. PLEASE CROSS-REFERENCE MFR.REPORT#8010047-2015-00816, 8010047-2015-00817, 8010047-2015-00818, 8010047-2015-00819, 8010047-2015-00820, 8010047-2015-00821, 8010047-2015-00822, 8010047-2015-00823, 8010047-2015-00983, 8010047-2015-00984, 8010047-2015-00985, 8010047-2015-00986, 8010047-2015-00987, 8010047-2015-00988, 8010047-2015-00989, 8010047-2015-00990, 8010047-2015-00991, 8010047-2015-00992, 8010047-2015-00993, 8010047-2015-00994, 8010047-2015-00995,8010047-2015-00997, 8010047-2015-01192, 8010047-2015-01193, 8010047-2015-01194, 8010047-2015-01195 AND 8010047-2015-01196.
OLYMPUS HAS REQUESTED THE RETURN OF THE TWO DUODENOSCOPE, BUT THE TWO SUBJECT DEVICES HAVE NOT RETURNED TO OLYMPUS. THOSE TWO DEVICES WERE MANUFACTURED RESPECTIVELY 30TH MAY 2011 AND 8TH AUG 2013, AND NO IRREGULARITY WAS IDENTIFIED IN THOSE DEVICES' DEVICE HISTORY RECORDS. OLYMPUS (B)(4) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS BUT WITH NO RESULT AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THE FOLLOWING TWELVE REPORTS WILL BE SUPPLEMENTED TO UPDATE ADDITIONAL INFORMATION: 8010047-2015-00816, 8010047-2015-00817, 8010047-2015-00818, 8010047-2015-00819,8010047-2015-00820, 8010047-2015-00821, 8010047-2015-00822, 8010047-2015-00823,8010047-2015-00983, 8010047-2015-00984, 8010047-2015-00985, AND 8010047-2015-00986.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "INDEPENDENT ROOT-CAUSE ANALYSIS OF CONTRIBUTING FACTORS, INCLUDING DISMANTLING OF 2 DUODENOSCOPES, TO INVESTIGATE AN OUTBREAK OF MULTIDRUG-RESISTANT KLEBSIELLA PNEUMONIAE". THE LITERATURE REPORTED INFORMATION ON THE AGE AND SEX OF 27 PATIENTS INFECTED WITH MULTIDRUG-RESISTANT KLEBSIELLA PNEUMONIAE. THE LITERATURE ALSO STATES THAT THERE WERE 15 PATIENTS WHO PERFORMED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN SCOPE A, 7 PATIENTS WHO PERFORMED ERCP PROCEDURE IN SCOPE B, 3 PATIENTS WHO PERFORMED ERCP PROCEDURE IN SCOPE A AND B, AND 2 PATIENTS WHO PERFORMED ERCP PROCEDURE IN SCOPE A OR B. THE LITERATURE STATES THAT THE 13 PATIENTS WHO DIED HAD AN INDEPENDENT COMMITTEE OF MEDICAL EXPERTS REVIEWED THE MEDICAL CHARTS AND CONSIDERED THEIR DEATHS NOT TO BE RELATED TO A POSSIBLE COLONIZATION OR INFECTION WITH THE OUTBREAK STRAIN. THIS MDR IS THE 15TH REPORT OF 15 PATIENTS WHO PERFORMED ERCP PROCEDURES AT SCOPE A. THIS MDR IS LITERATURE INFORMATION FOR THE EVENTS REPORTED IN THE FOLLOWING MDR NUMBERS. ADDITIONAL INFORMATION IN THESE MDRS WILL FOLLOWUP IN EACH MDR. MDR REPORT NUMBERS; 8010047-2015-00816, 8010047-2015-00817, 8010047-2015-00818, 8010047-2015-00819, 8010047-2015-00820, 8010047-2015-00821, 8010047-2015-00822, 8010047-2015-00823, 8010047-2015-00983, 8010047-2015-00984, 8010047-2015-00985, 8010047-2015-00986, 8010047-2015-00987, 8010047-2015-00988, 8010047-2015-00989, 8010047-2015-00990, 8010047-2015-00991, 8010047-2015-00992, 8010047-2015-00993, 8010047-2015-00994, 8010047-2015-00995, 8010047-2015-00996, 8010047-2015-00997, 8010047-2015-01192, 8010047-2015-01193, 8010047-2015-01194, 8010047-2015-01195, 8010047-2015-01196.
OLYMPUS (B)(4) WAS INFORMED OF ADDITIONAL INFORMATION FROM A MEETING WITH THE USER FACILITY ON (B)(6) 2015 AFTER SUBMITTING THE MDR REPORTING THE 23 PATIENTS. PATIENT NO.1 WAS ADMITTED TO A HOSPITAL FOR (B)(6) ON (B)(6) 2014 AND ISOLATED. PATIENT NO.1 WAS TESTED (B)(6) 2015. THE FACILITY SENT A SAMPLE OF PATIENT NO.1 TO AN EXTERNAL INSTITUTE AND CONFIRMED THAT THIS (B)(6). PATIENT NO.2 WAS TRANSFERRED TO THE SAME ROOM OF PATIENT NO.1 ON (B)(6) 2015. PATIENT NO.2 WAS TESTED (B)(6) ON (B)(6) 2015. ACCORDING TO THE INVESTIGATION BY THE FACILITY, THE (B)(6) DETECTED FROM PATIENT NO.1 AND NO.2 WERE CONFIRMED GENETICALLY-IDENTICAL PROPERTY. THE FACILITY STOPPED USING TJF-Q180V ON (B)(6) 2015. THE FACILITY NOTIFIED ALL PATIENTS WHO UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING TJF-180/160 SERIES BETWEEN (B)(6) 2015. THE PATIENTS WHO UNDERWENT AN ERCP PROCEDURE IN THE FACILITY WERE COUNTED 102 AS OF (B)(6) 2015. 28 PATIENTS OF THEM WERE TESTED (B)(6). 25 PATIENTS OF THE 28 WERE CONFIRMED (B)(6). THE FACILITY IS IN PROCESS OF IDENTIFYING THE PROPERTY OF THE (B)(6) DETECTED FROM THE OTHER 3 PATIENTS. THE INFORMATION ON THE OUTCOME OF THE 28 PATIENTS WHO WERE TESTED (B)(6) IS UNKNOWN. NO PATIENT DEATH IS REPORTED IN THE 28 PATIENTS AT THIS TIME. THIRTEEN (13) OUT OF THE102 PATIENTS REPORTEDLY DECEASED WITHOUT CULTURES BEING TAKEN. THERE IS NO REPORT OF INFORMATION ON THE RELATIONSHIP OF A TJF-Q180V TO THE DECEASE. OLYMPUS HAD BEEN INFORMED OF THE INFECTION OF THE 23 PATIENTS IN TOTAL. ACCORDING TO THE INFORMATION ABOVE, OLYMPUS WILL SUBMIT ADDITIONAL 5 INITIAL MDRS TO ACCOUNT FOR THE TOTAL OF 28 PATIENTS. (PLEASE CROSS REFERENCE 8010047-2015-01192,8010047-2015-01193,8010047-2015-01194,8010047-2015-01195 AND 8010047-2015-01196) THE FACILITY PROVIDED THE MONTHLY NUMBER OF THE PATIENTS WHO UNDERWENT AN ERCP PROCEDURE USING A TJF-Q180V BETWEEN (B)(6) 2015. AMONG THE PATIENTS WHO UNDERWENT AN ERCP PROCEDURE USING TJF-Q180V (SN: (B)(4)), THE PATIENTS WHO WERE TESTED POSITIVE FOR THE MICROORGANISM WERE IDENTIFIED RESPECTIVELY 1 PATIENT IN (B)(6) 2015, 4 PATIENTS IN (B)(6) 2015, 2 PATIENTS IN (B)(6) 2015, 2 PATIENTS IN (B)(6) 2015, 0 PATIENT IN (B)(6) 2015, 3 PATIENTS IN (B)(6) 2015, 1 PATIENT IN (B)(6) 2015 AND 0 PATIENT IN (B)(6) 2015. AMONG THE PATIENTS WHO UNDERWENT AN ERCP PROCEDURE USING TJF-Q180V (SN: (B)(4)), THE PATIENTS WHO WERE TESTED POSITIVE FOR THE MICROORGANISM WERE IDENTIFIED RESPECTIVELY, 0 PATIENT BETWEEN (B)(6) 2015, 1 PATIENT IN (B)(6) 2015, 4 PATIENTS IN (B)(6) 2015 AND 2 PATIENTS IN (B)(6) 2015. -AMONG THE PATIENTS WHO UNDERWENT AN ERCP PROCEDURE USING EITHER TJF-Q180V(SN:(B)(4)) OR TJF-Q180V(SN:(B)(4)) , THE PATIENTS WHO WERE TESTED POSITIVE FOR THE MICROORGANISM WERE IDENTIFIED RESPECTIVELY, 1 PATIENT IN (B)(6) 2015, 2 PATIENTS IN (B)(6) 2015. NO PATIENT WAS IDENTIFIED IN THE OTHER MONTHS. THE TIME OF ERCP PROCEDURE THAT THE 5 POSITIVE PATIENTS OF THE TOTAL 28 PATIENT REPORTED BY THE FACILITY WAS UNKNOWN. ADDITIONALLY, THE FACILITY PERFORMED TWO CULTURE TESTS IN TOTAL ON THE TJF-Q180V(SN: (B)(4)) AND TJF-Q180V(SN:(B)(4)). CULTURE TEST RESULT : 2101841 THE 1ST CULTURE TEST PERFORMED ON (B)(6) 2015 FOUND THAT THE FOLLOWING MICROORGANISMS WERE DETECTED FROM THE SUCTION CHANNEL: STENOTROPHOMONAS MALTOPHILIA,PSEUDOMONAS AERUGINOSA,ENTEROBACTER CLOACAE COMPLEX, (B)(6), AND THE FOLLOWING MICROORGANISMS WERE DETECTED FROM THE INSTRUMENT CHANNEL: (B)(6) ,STENOTROPHOMONAS MALTOPHILIA, (B)(6). THE 2ND CULTURE TEST PERFORMED ON (B)(6) 2015 FOUND THAT THE FOLLOWING MICROORGANISMS WERE DETECTED FROM THE SUCTION CHANNEL: CITROBACTER FREUNDII ESBL POSITIVE, STAPHYLOCOCCUS EPIDERMIDIS,STENOTROPHOMONAS MALTOPHILIA, ENTEROBACTER CLOACAE COMPLEX,AND THE FOLLOWING MICROORGANISMS WERE DETECTED FROM THE INSTRUMENT CHANNEL: (B)(6) PNEUMONIAE ESBL POSITIVE,CITROBACTER FREUNDII ESBL POSITIVE, STENOTROPHOMONAS MALTOPHILIA. CULTURE TEST RESULT : 2304233 THE 1ST CULTURE TEST PERFORMED ON (B)(6) 2015 FOUND THAT THE FOLLOWING MICROORGANISMS WERE DETECTED FROM THE INSTRUMENT CHANNEL: (B)(6), ESCHERICHIA COLI ESBL POSITIVE. THE 2ND CULTURE TEST PERFORMED ON (B)(6) 2015 FOUND THAT THE FOLLOWING MICROORGANISMS WERE DETECTED FROM THE INSTRUMENT CHANNEL: (B)(6).
MICROORGANISM WAS DETECTED FROM THE PATIENT ON (B)(6) 2015. THE PATIENT UNDERWENT ERCP ON (B)(6) 2015. THE PATIENT WAS DISCHARGED.
AFTER SUBMITTING MDR REPORTS ON 12 PATIENTS, OLYMPUS RECEIVED ADDITIONAL INFORMATION THAT A TOTAL OF 23 PATIENTS WERE INFECTED WITH (B)(6) AFTER UNDERGOING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING A TJF-Q180V BETWEEN (B)(6) 2015. THE FACILITY IS NOTIFYING AFFECTED PATIENTS. AN UNSPECIFIED NUMBER OF THESE PATIENTS EXPIRED. THE EXACT CAUSE OF PATIENT'S OUTCOME IS UNKNOWN. THE USER FACILITY HAS TWO TJF-Q180V ENDOSCOPES. (SERIAL NUMBERS ARE (B)(4)). IT IS UNKNOWN WHICH SCOPE WAS USED FOR EACH PATIENT. (B)(6) FOUND IN THE INFECTED PATIENTS WAS ALSO DETECTED FROM THE INSTRUMENT CHANNEL OF THE BOTH ENDOSCOPES. THE USER FACILITY WAS USING AN ETD3 AUTOMATED ENDOSCOPE REPROCESSOR WITH PERIACETIC ACID DISINFECTANT SOLUTION. ORIGINALLY, OLYMPUS WAS INFORMED OF 12 PATIENT INFECTIONS. BASED ON THE NEW INFORMATION RECEIVED, OLYMPUS WILL SUBMIT ELEVEN INITIAL MDR'S TO ACCOUNT FOR THE TOTAL OF 23 PATIENTS. (PLEASE CROSS REFERENCE 8010047-2015-00987,8010047-2015-00988,8010047-2015-00989,8010047-2015-00990,8010047-2015-00991, 8010047-2015-00992,8010047-2015-00993,8010047-2015-00994,8010047-2015-00995,8010047-2015-00996 AND 8010047-2015-00997).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726656 | EVIS EXERA II DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | OLYMPUS MEDICAL SYSTEMS CORPORATION | TJF-Q180V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death| O |