EVIS EXERA III DUODENOVIDEOSCOPE
Report
- Report Number
- 8010047-2022-06843
- Event Type
- Malfunction
- Date Received
- April 21, 2022
- Date of Event
- March 27, 2022
- Report Date
- June 15, 2022
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDT
- PMA / PMN Number
- K202661
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE DEVICE TESTED POSITIVE WITH MICROORGANISM WITH THE FOLLOWING: CULTURE TEST ON (B)(6) 2022- DEVICE TESTED POSITIVE WITH KLEBSIELLA PNEUMONIAE 100 CFU/100 ML AND CANDIDA ALBICANS DUBLINIENSIS 200 CFU/100 ML. THE DEVICE WAS THEN SENT TO OLYMPUS HAMBURG SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) PERFORMED A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED. THE MICROBIOLOGICAL TEST AT THE INSTITUTE FOR HYGIENE AND ENVIRONMENT IN HAMBURG REPORTED NO GERMS HAVE BEEN FOUND ON THIS INSTRUMENT. ALL CHANNELS HAVE BEEN CHECKED WITHOUT FINDING ANY GERMS. THE SUBJECT DEVICE WAS THEN RETURNED TO OLYMPUS FOR EVALUATION. SERVICE REPAIR PERFORMED PHYSICAL INVESTIGATION AND NOTED THE INSERTION TUBE BENDING SECTION RUBBER GLUE CONDITION WAS POROUS( FAILED THE VISUAL BENCH CHECKS). THE AIR LEAK UNIT CHECK, IMAGE CHECK , IMAGE LIGHT TRANSMISSION, FUNCTION CHECKS FOR RAISER SYSTEM, CHANNEL SYSTEM AND ANGULATION SYSTEM WERE CHECKED AND PASSED THE INSPECTION. ADDITIONALLY, SERVICE REPAIR NOTED THAT SOME MATERIALS WEAR OVER TIME AND NEED TO BE REPLACED. THESE ARE REPLACEMENT OF ALL CHANNELS AND CYLINDERS . BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: AER/EWD WAS NOT TESTED. AER/EWD REPROCESSOR: MODEL IS GETINGE, DETERGENT NAME: NOT PROVIDED, DISINFECTANT NAME: NOT PROVIDED. PRE-CLEANING: ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL. FLUSHING. CHANNELS ARE: A/W CHANNEL (AIR/WATER CHANNEL), FORCEPS ELEVATOR WIRE CHANNEL. DETERGENT USED : NOT PROVIDED, MANUAL CLEANING : NOT PROVIDED, BRUSH POINTS: NOT PROVIDED. STORAGE: DRYNG CABINET : MODEL IS GETINGE, SCOPE NOT STERILIZED. SCOPE MAINTENANCE/REPAIR: BY OLYMPUS. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.
CORRECTION TO DATE REC¿D BY MFR OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 27-MAR-2022. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
CUSTOMER REPORTED WITH A DESCRIPTION OF "GROWTH IN THE OPENING OF THE WORK CHANNEL". THE ISSUE FOUND DURING A CULTURE TEST ON THE SUBJECT DEVICE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2327135 | EVIS EXERA III DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | OLYMPUS MEDICAL SYSTEMS CORP. | TJF-Q190V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |