EVIS LUCERA ELITE DUODENOVIDEOSCOPE
Report
- Report Number
- 9610595-2023-18412
- Event Type
- Injury
- Date Received
- November 30, 2023
- Date of Event
- October 13, 2023
- Report Date
- February 7, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND INFORMATION RECEIVED FROM THE FACILITY (PER CAPA-201237 INVESTIGATION ACTIVITIES). THE DEVICE HISTORY RECORD WAS NOT REVIEWED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONFIRMED THAT THE FACILITY DEVIATED FROM REPROCESSING STEPS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU) MANUAL (SPECIFICALLY FAILED TO PRACTICE PRECLEANING CORRECTLY). HOWEVER, A RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENT COULD NOT BE IDENTIFIED. THEREFORE, SINCE THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ THE FOLLOWING INFORMATION WAS PROVIDED BY THE FACILITY IN RESPONSE TO (CAPA-201237) INVESTIGATION ACTIVITIES PERFORMED BY OLYMPUS: THE FACILITY REPORTED THAT AT THE TIME OF THE EVENT, DEVICE REPROCESSING WAS CONDUCTED ACCORDING TO THE OLYMPUS INSTRUCTIONS FOR USE (IFU) MANUAL. HOWEVER, IT WAS NOTED THAT THE PRE-CLEANING OF THE ENDOSCOPE WAS SIMPLIFIED (SUCTIONING, ETC.,), AND IMPROVEMENT IS NEEDED. PER THE FACILITY, THE ENDOSCOPES ARE REPROCESSED USING THE OLYMPUS ENDOSCOPE REPROCESSOR (OER-5). DURING CLEANING, AN IFU APPROVED DETERGENT AND AN OLYMPUS BRUSH IS USED. HOWEVER, IT WAS ALSO DISCLOSED THAT THE ENDOSCOPES ARE WASHED ONCE WITH JOY DISH DETERGENT DURING PRE-CLEANING OF THE DEVICE. A CULTURE TEST (FOR RINSE WATER) OF THE OER-5 IS NOT CONDUCTED BY THE FACILITY. THE OER-5 FILTER IS REPLACED ONCE A MONTH, AND WATER LINE DISINFECTION IS CONDUCTED EVERY TWO WEEKS. ALSO, DISTILLED WATER IS USED IN THE WATER CONTAINER DURING PROCEDURES. ONCE CLEANED, EACH CHANNEL IS BLOWN WITH ENDO PUSH FOR FIVE SECONDS. THE ENDOSCOPE IS THEN HUNG THE STORAGE CABINET. THE AREA THAT IS IN CONTACT WITH THE STORAGE CABINET IS COVERED WITH A WATER-ABSORBING SHEET (WHICH IS REPLACED EVERY TWO WEEKS). A DESICCANT IS PLACED IN THE STORAGE CABINET WITH THE DATE WRITTEN ON TOP OF IT. THE DESICCANT IS REPLACED ONCE A MONTH. HOWEVER, THE FREQUENCY OF REPLACEMENT IS CHANGED DURING PERIODS OF HIGH HUMIDITY (SUMMER, ETC.,). BEFORE AND AFTER EACH USE, THE DEVICES ARE INSPECTED FOR ABNORMAL FUNCTIONAL ISSUES, BUT NOT INSPECTED FOR DAMAGE. DEVICES ARE SENT FOR REPAIR IF A FUNCTIONAL ABNORMALITY IS FOUND, OR IF INSTRUCTED BY THE PHYSICIAN. THE FACILITY CONFIRMED THAT DEVICES ARE ONLY SENT TO OLYMPUS FOR REPAIR, AND NEVER TO A THIRD-PARTY. AFTER THE REPORTED ADVERSE EVENT (INFECTION OUTBREAK), THE FACILITY CONDUCTED A ¿STUDY SESSION¿ AND PRACTICE PERFORMING DEVICE REPROCESSING WAS COMPLETED BY ALL STAFF, INCLUDING THOSE WHO DO NOT NORMALLY REPROCESS THE DEVICE. SINCE THE EVENT, THE FACILITY HAS DECIDED TO CONDUCT A CULTURE TEST TWICE A MONTH IN ACCORDANCE WITH THE INSTRUCTIONS OF THE INFECTION CONTROL DEPARTMENT. NURSES AT THE FACILITY ATTEND A LECTURE ON THE STRUCTURE OF THE ENDOSCOPES AND PRACTICE PERFORMING CLEANING METHODS FROM THE DISTRIBUTOR. THE DEVICE REPROCESSING STAFF AT THE FACILITY, ARE PROVIDED TRAINING/INSTRUCTION BY A TRAINER ON CLEANING THE DEVICES AND TAKE ABOUT 1 TO 1.5 MONTHS TO BECOME INDEPENDENT. IT WAS REPORTED BY THE FACILITY THAT WHILE THE TRAINER WAS ON TEMPORARY LEAVE, SEVERAL DEVICE REPROCESSING STAFF MEMBERS WERE REPLACED. HOWEVER, THE FACILITY STATED THAT IT IS ASSUMED THAT DEVICE REPROCESSING IS CONDUCTED PROPERLY EVEN IF AN INFECTION OCCURRED. FURTHERMORE, IT WAS DISCLOSED BY THE FACILITY THAT THERE WAS ONLY ONE CASE WHERE A DEVICE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THE OUTER SURFACE OF THE UPPER ENDOSCOPE TESTED POSITIVE; HOWEVER, IT WAS DETERMINED BY THE FACILITY THAT THE CONTAMINATION OCCURRED BECAUSE THE OUTER SURFACE OF THE DEVICE WAS HANDLED BY HANDS THAT HAD TOUCHED A DIRTY VALVE. THIS CASE HAS ALREADY BEEN REPORTED TO THE INFECTION CONTROL DEPARTMENT. THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION ADDED TO B5, D4 AND G2 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION TO THE PREVIOUS SUBMISSION. THE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE PREVIOUS SUBMISSION INCLUDES THE CUSTOMER'S CLEANING DISINFECTION AND SANITIZATION (CDS) PRACTICES. PLEASE SEE BELOW. THE USER PROVIDED THEIR CDS PRACTICES OF THE SUBJECT DEVICE AS FOLLOWS: IT IS UNKNOWN IF PRE-CLEANING WAS PERFORMED IMMEDIATELY AFTER THE PROCEDURE. WATER WAS ASPIRATED THROUGH THE INSTRUMENT/SUCTION CHANNEL WITH A SUCTION PUMP. THE FORCEPS ELEVATOR WAS NOT RAISED AND LOWERED THREE TIMES IN WATER DURING ASPIRATION. ALSO, THE AIR/WATER (A/W) CHANNEL WAS NOT FLUSHED WITH WATER AND AIR BY USING THE A/W CHANNEL CLEANING ADAPTER (MH-948). PRE-SOAKING OF THE DEVICE WAS NOT PERFORMED PRIOR TO CLEANING. THE DEVICE PASSED THE LEAK TEST. THE DETERGENT USED FOR CLEANING WAS ENDOFRESH S. BRUSHING WAS PERFORMED AT THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, AND THE FORCEPS ELEVATOR. THE FORCEPS ELEVATOR WAS NOT RAISED AND LOWERED THREE TIMES WHILE SUBMERGED IN THE DETERGENT SOLUTION. HOWEVER, THE FORCEPS ELEVATOR WAS FLUSHED, AND THE DISTAL END WAS FLUSHED WITH THE DISTAL END FLUSHING ADAPTOR (MAJ-2319). THE AUTOMATED ENDOSCOPE REPROCESSOR USED WAS THE OLYMPUS OER-5. THERE WERE NO DEFECTS OBSERVED WITH THE OER-5 DEVICE. THE DETERGENT USED WITH THE OER-5 WAS ENDOQUICK, AND THE DISINFECTANT USED WAS ACECIDE. ALL CHANNELS WERE CONNECTED WITH THE CLEANING TUBES WHILE SETTING UP INTO THE OER-5. THE DISINFECTANT EXPIRATION WAS CONTROLLED, AND THE DISINFECTANT SOLUTION MET THE MINIMUM EFFECTIVE CONCENTRATION. ALSO, THE WATER QUALITY OF THE RINSE WATER WAS CONTROLLED, AND THE WATER FILTER REPLACED PERIODICALLY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU).
THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED: IT WAS REPORTED THAT THE OLYMPUS ENDOSCOPE REPROCESSOR (OER-5) WAS USED AT THE TIME OF THE EVENT. HOWEVER, THE FACILITY STATED THAT THE OER-5 IS NOT THE SUSPECT IN THIS INCIDENT, AND CULTURE TESTING IS NOT CONDUCTED ON THE DEVICE. PER THE FACILITY, IT WAS INITIALLY SUSPECTED THAT AN OLYMPUS ENDOSCOPE CAUSED THE REPORTED PATIENT INFECTIONS; HOWEVER, SUBSEQUENT CULTURE TESTING RESULTS CONFIRMED THAT THE STRAIN OF BACTERIA DIFFERED BETWEEN PATIENTS. THIS LEADS TO THE CONCLUSION THAT THE INFECTION WAS NOT A CROSS-CONTAMINATION WITHIN THE HOSPITAL. FURTHERMORE, ALTHOUGH FEVER WAS REPORTED IN TWO PATIENTS, THE PATIENTS ARE REPORTEDLY ¿DOING WELL AND RECOVERING.¿ NO MEDICAL TREATMENT OR INTERVENTIONS WERE REQUIRED. ALTHOUGH BLOOD SAMPLES FROM THE PATIENTS WERE OBTAINED, THE SPECIFIC TYPE OF SAMPLES WERE REPORTED AS UNKNOWN. IN ADDITION, NO CULTURE TESTS WERE CONDUCTED ON ANY OF THE ENDOSCOPES INVOLVED IN THIS EVENT; HOWEVER, CULTURE TESTS ARE CONDUCTED ON ALL DEVICES PERIODICALLY PER FACILITY PROCEDURE.
THE CUSTOMER REPORTED TO OLYMPUS THAT PSEUDOMONAS AERUGINOSA OR ESCHERICHIA COLI )E.COLI) INFECTION WAS DETECTED IN FIVE PATIENTS AFTER HAVING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WHEN USING AN EVIS LUCERA ELITE DUODENOVIDEOSCOPE AND/OR A EVIS LUCERA ELITE DUODENOVIDEOSCOPE. TWO SCOPES WERE USED, BUT IT WAS UNKNOWN WHICH SCOPE WAS USED ON WHICH PATIENT. ERCPS WERE PERFORMED ON (B)(6) 2023, (B)(6) 2023 AND (B)(6) 2023 ON THREE PATIENTS, WHO LATER WENT ON TO TEST POSITIVE FOR E. COLI. THE PATIENT WHO HAD THEIR ERCP PERFORMED ON (B)(6) 2023 HAD A FEVER AND WAS "NOT IN GOOD CONDITION." IT WAS ALSO REPORTED THAT PSEUDOMONAS AERUGINOSA WAS DETECTED IN PATIENTS THAT HAD ERCP'S PERFORMED ON (B)(6) 2023 AND (B)(6) 2023; THE ORGANISM WAS DETECTED IN BLOOD, NOT BILE. HOWEVER, TEST RESULTS FOR PSEUDOMONAS AERUGINOSA AND E. COLI STRAINS WERE ALL INCONSISTENT, AND THE FACILITY CONCLUDED THAT THERE IS A DIFFERENCE IN MICROORGANISM SPECIES AMONG THE PATIENTS, THE CAUSE COULD BE NOSOCOMIAL (IN-HOSPITAL CROSS-INFECTION) AS THESE WERE ALL HOSPITALIZED PATIENTS. IN ADDITION, IT WAS STATED THAT BEDSIDE WASHING HAD NOT BEEN PERFORMED ACCURATELY AT THE FACILITY. NO BACTERIA HAS BEEN DETECTED ON THE REPORTED SCOPE IN THE PAST AND NO ENVIRONMENTAL INVESTIGATION HAS BEEN CONDUCTED AT THE TIME OF THE REPORT. NO MEDICAL INTERVENTIONS WERE REPORTED FOR ANY OF THE PATIENTS. OF NOTE, ONE OF THE SCOPES WAS REPORTED TO BE USED ON (B)(6) 2023; ALTHOUGH NO INJURIES OR INFECTIONS HAVE BEEN REPORTED FROM THAT EXAM DATE. ADDITIONAL INFORMATION REGARDING SPECIFICS ABOUT ALL OF THE PATIENTS HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PATIENT 1 OF 5 PATIENT IDENTIFIER (B)(6) FOR DEVICE 1 OF 2, TJF-Q290V . PATIENT IDENTIFIER (B)(6) FOR DEVICE 2 OF 2, TJF-260V. PATIENT 2 OF 5 PATIENT IDENTIFIER (B)(6) FOR DEVICE 1 OF 2, TJF-Q290V . PATIENT IDENTIFIER (B)(6) FOR DEVICE 2 OF 2, TJF-260V. PATIENT 3 OF 5 PATIENT IDENTIFIER (B)(6) FOR DEVICE 1 OF 2, TJF-Q290V . PATIENT IDENTIFIER (B)(6) FOR DEVICE 2 OF 2, TJF-260V. PATIENT 4 OF 5 PATIENT IDENTIFIER (B)(6) FOR DEVICE 1 OF 2, TJF-Q290V . PATIENT IDENTIFIER (B)(6) FOR DEVICE 2 OF 2, TJF-260V. PATIENT 5 OF 5 PATIENT IDENTIFIER (B)(6) FOR DEVICE 1 OF 2, TJF-Q290V . PATIENT IDENTIFIER (B)(6) FOR DEVICE 2 OF 2, TJF-260V. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) FOR DEVICE TJF-Q290V.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1633788 | EVIS LUCERA ELITE DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q290V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |