FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
Report
- Report Number
- 9610595-2024-06726
- Event Type
- Injury
- Date Received
- March 30, 2024
- Report Date
- November 14, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FGB
- UDI-DI
- 04953170063114
- PMA / PMN Number
- K912120
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A CLEANING, DISINFECTION AND STERILIZATION CHECKLIST WAS PROVIDED. THE DEVICES HAVE BEEN RE-PROCESSED AND STORED AS THEY ALWAYS ARE. PRE-CLEANING WAS PERFORMED IMMEDIATELY AFTER THE PATIENT PROCEDURE. WATER WAS NOT ASPIRATED THROUGH THE INSTRUMENT/SUCTION CHANNEL WITH A SUCTION PUMP. THE INSTRUMENT/SUCTION CHANNEL WAS BRUSHED. THE DEVICE WAS NOT RINSED BEFORE MANUAL DISINFECTION. ALL CHANNELS WERE FLUSHED WITH AND IMMERSED INTO THE DISINFECTANT. THE CONCENTRATION AND EXPIRATION DATE OF DISINFECTANT WERE CONTROLLED. THE AER/EWD USED WAS MINIETD2. THERE WERE NO DEFECTS ON AER/EWD. ALL CHANNELS WERE CONNECTED WITH TUBES WHEN THE ENDOSCOPE WAS SETTING UP INTO THE AER/EWD. THE CONCENTRATION AND EXPIRATION DATE OF DISINFECTANT WERE CONTROLLED. THE WATER QUALITY OF THE RINSE WATER WAS CONTROLLED. AFTER PROCESSING, THE DEVICE WAS NOT DRIED. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING (PRIOR TO CLEANING, DISINFECTION AND STERILIZATION OF (B)(6) BY OLYMPUS): SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: SAMPLING SOLUTION INSTRUMENT/BIOPSY/SUCTION CHANNEL CFU: (B)(4) BACTERIAL IDENTIFICATION: (B)(4). SAMPLING (PRIOR TO CLEANING, DISINFECTION AND STERILIZATION OF (B)(6) BY OLYMPUS): SAMPLING DATE: (B)(6) 2024 SAMPLING FROM: SAMPLING OF SWABBING DISTAL END UNIT CFU: (B)(4) BACTERIAL IDENTIFICATION: NO DETECTION. SAMPLING (AFTER CLEANING, DISINFECTION AND STERILIZATION OF (B)(6) BY OLYMPUS): SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: SAMPLING SOLUTION INSTRUMENT/BIOPSY/SUCTION CHANNEL AND SAMPLING OF SWABBING DISTAL END UNIT. CFU: (B)(4) BACTERIAL IDENTIFICATION: NO DETECTION. THIS MEDWATCH IS RELATED TO MFR REPORT NUMBERS 9610595 - 2024 - 00012, 9610595 - 2024 - 05853, AND 9610595 - 2024 - 00480.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURE'S (LM) REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES, TO PROVIDE ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW UP (H11), AND TO PROVIDE RESULTS OF LM INVESTIGATION INADVERTENTLY LEFT OUT (H6 AND H11-IFU STATEMENT). ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT PRIOR TO THE CONTAMINATION EVENT, OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAD CARRIED OUT THE PROCESS REVIEW TO THIS DEPARTMENT AND INFORMED THEM OF THE FAILURES THEY HAD DETECTED IN THE REPROCESSING. IN CONCLUSION, ON SEVERAL OCCASIONS, THE CUSTOMER WAS ALERTED TO THE RISKS, AS WAS THE PREVENTIVE DEPARTMENT, BUT SO FAR OLYMPUS HAS NOT SEEN ANY CHANGES IN DAILY PRACTICE. ADDITIONALLY, THE FIRST TRAINING DATE OCCURRED ON NOVEMBER 10, 2023 AND SECOND TRAINING DATE OCCURRED ON APRIL 6, 2024. THE LM REVIEWED THE CUSTOMERS PROVIDED THE CDS PROCESSES WHERE THE FOLLOWING WAS CONFIRMED TO BE A FAIL: ENDOSCOPE FIRMLY AND STABLY POSITIONED ON ITS HANGER. PRE-CLEANING OF ORGANIC RESIDUES ON THE SURFACE OF THE ENDOSCOPE WITH ENZYMATIC SOLUTION. ASPIRATION OF THE WORKING CHANNEL/ASPIRATION MINIMUM 30 SECONDS. USE OF ENZYMATIC DETERGENT IN ADEQUATE CONCENTRATIONS. ENDOSCOPE WELL-CONDITIONED DURING PRE-CLEANING. (NO PRE-CLEANING IS PERFORMED). TRANSPORT: ENDOSCOPE HANDLED WITH BOTH HANDS DURING TRANSPORT OR IN TRAYS, WITHOUT RISK OF DAMAGE. PERFORMING A MANUAL LEAK TEST TO DETECT POSSIBLE LEAKAGE BY CORRECTLY FOLLOWING THE STEPS INDICATED IN THE MANUAL. BRUSHING PERFORMED CORRECTLY AND WITH ENZYMATIC DETERGENT, WITH THE ENDOSCOPE SUBMERGED. (THE USERS DO NOT HAVE BRUSHES FOR CLEANING THE CHANNELS.) USE OF SUITABLE ADAPTERS FOR CLEANING, ESPECIALLY WITH THE ENDOSCOPES THAT HAVE AUXILIARY WATER CHANNELS, CHANNEL OF THE ELEVATING FINGERNAIL / ELEVATING FINGERNAIL. PROPER USE OF BRUSHES, TAKING INTO ACCOUNT THE DIAMETER OF THE CHANNELS TO BE BRUSHED. SINGLE-USE BRUSHES. THE ENDOSCOPE IS KEPT WELL-CONDITIONED AND IN AN UPRIGHT POSITION WHILE WAITING FOR THE NEXT SCAN. THE ENDOSCOPE IS PROPERLY CONDITIONED THROUGHOUT THE MANUAL CLEANING PROCESS WITHOUT RISK OF DAMAGE. DRYING CABINET WITH CONTROLLED MEDICAL AIR. (THERE ARE NO CABINETS FOR EQUIPMENT STORAGE.) CAUTION TO AVOID DAMAGE TO THE ENDOSCOPE WHEN STORING IT IN ITS CABINET. ENDOSCOPES STORED WITHOUT VALVES AND SEALING CAPS IN PLACE. THE REPROCESSING ROOM HAS A WELL SEPARATED CLEAN AND DIRTY AREA. USER MANUALS AND CLEANING GUIDES AVAILABLE. THE SERVICE IS TRACEABLE. (THE USERS DO NOT HAVE TRACEABILITY.) THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE DHR WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE CASE IS NOT DUE TO DESIGN. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. HOWEVER, IT¿S LIKELY THE CAUSE IS RELATED TO THE USER DEVIATING FROM THE REPROCESSING STEPS RECOMMENDED BY OLYMPUS, AND A DIFFERENCE IN RECOGNITION ON HANDLING OR REPROCESSING STEPS BETWEEN OLYMPUS¿ RECOMMENDATION AND THE USER FACILITY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION TO FIELD H3 AND H6, AS THE SUBJECT DEVICE WAS NOT RETURNED TO THE FACILITY FOR EVALUATION.
IT WAS REPORTED, THERE WAS LEAKAGE AND PSEUDOMONAS CONTAMINATION WITH THE VISERA CYSTO-NEPHRO VIDEOSCOPE. THE MICROBIOLOGY TEST REPORTED A POSITIVE SAMPLE. PATIENTS WITH INFECTION BEGAN TO ARRIVE, THE AMOUNT OF PATIENTS OR TYPE OF INFECTION WAS NOT SPECIFIED. IT WAS IDENTIFIED THAT THESE PATIENTS HAD RECENTLY UNDERGONE CYSTOSCOPY PROCEDURES, THEREFORE THE CYSTOSCOPES AND WASHING MACHINES WERE TESTED, AND ONE OF THE SCOPES TESTED POSITIVE. AROUND 20 DAYS PRIOR, CUSTOMER HAD PERFORMED CULTURE TESTS IN ALL THE DEVICES AND THE RESULTS WERE CORRECT. AN ASSESSMENT WAS PERFORMED BY AN OLYMPUS FIELD SERVICE ENGINEER AND IT WAS FOUND THAT THE USE OF THE IRRIGATION PLUG WAS NOT REPROCESSED CORRECTLY. THE CUSTOMER EXPLAINED THEY USUALLY DISASSEMBLE AND PLUNGE IN THE SAME DISINFECTANT SOLUTION THEY USE WITH THE CYSTOSCOPES. THEY DO NOT BRUSH, THEY ONLY RINSE BEFORE INTRODUCING IN THE DISINFECTANT SOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2259252 | FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) | FORCEPS/ IRRIGATION PLUG | FGB | AIZU OLYMPUS CO., LTD. | MAJ-891 | 04953170063114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | VISERA CYSTO-NEPHRO VIDEOSCOPE (CYF-VA2) |