EVIS EXERA III DUODENOVIDEOSCOPE
Report
- Report Number
- 8010047-2022-11999
- Event Type
- Malfunction
- Date Received
- July 15, 2022
- Date of Event
- June 22, 2022
- Report Date
- May 14, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- UDI-DI
- 04953170452024
- PMA / PMN Number
- K220587
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
CUSTOMER INDIANA UNIVERSITY HEALTH (IU HEALTH) FACILITIES HAD CONCERNS CONNECTED WITH REPROCESSING OF DEVICES AT THE VARIOUS IU HEALTH FACILITIES. ARISING FROM THIS CONCERN, DEVICES/EVENTS HAVE BEEN IDENTIFIED FOR THE IU HEALTH FACILITIES BELOW: INDIANA UNIVERSITY HEALTH BEDFORD INC. INDIANA UNIVERSITY HEALTH BLOOMINGTON INC. BLOOMINGTON ENDOSCOPY CENTER LLC (BEC) INDIANA UNIVERSITY HEALTH MORGAN HOSPITAL INC. INDIANA UNIVERSITY HEALTH NORTH HOSPITAL INC. INDIANA UNIVERSITY HEALTH PAOLI INC. THE ASSOCIATED DEVICES/EVENTS THAT ARE IDENTIFIED AT THIS TIME FOR BLOOMINGTON HOSPITAL ARE AS BELOW: PATIENT IDENTIFIER MODEL NUMBER SERIAL NUMBER (B)(6) PCF-H190L (B)(4) (B)(6) PCF-H190L (B)(4) (B)(6) GIF-1TH190 (B)(4) (B)(6) GIF-H190 (B)(4) (B)(6) SIF-Q180 (B)(4) (B)(6) GIF-H190 (B)(4) (B)(6) GIF-H190 (B)(4) (B)(6) GF-UCT180 (B)(4) (B)(6) PCF-H190L (B)(4) (B)(6) TJF-Q190V (B)(4) (B)(6) TJF-Q190V (B)(4). (FIRST EVENT) .(B)(6) TJF-Q190V (B)(4) (SECOND EVENT). THIS MEDWATCH IS FOR PATIENT IDENTIFIER: (B)(6). IN-SERVICE WAS PERFORMED BY THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) FOR THE FACILITY¿S REPROCESSING. THE CLEANING, DISINFECTION, AND STERILIZATION INFORMATION WAS REVIEWED DURING IN-SERVICE AND DOCUMENTED. BELOW ARE THE OBSERVATIONS MADE: DURING REPROCESSING IN-SERVICE IT WAS OBSERVED THAT THE CUSTOMER USES THE CHANNEL OPENING CLEANING BRUSH PRIOR TO USING THE CHANNEL CLEANING BRUSH. THE BRUSHING IS DONE IN THE INCORRECT ORDER. THE CUSTOMER USES THIRD PARTY BRUSHES. THE CUSTOMER ALSO DOES NOT WIPE THE SCOPE DOWN AFTER THE FLUSHING WITH DETERGENT SOLUTION AND DOES NOT LET IT SOAK FOR THE DETERGENT MANUFACTURER'S RECOMMENDED TIME. THE SCOPE DOES NOT SOAK AT ALL AND GOES DIRECTLY INTO THE RINSE SINK. THE CUSTOMER USES INTERCEPT DETERGENT. THE CUSTOMER USES THE SCOPE BUDDY PLUS FOR FLUSHING AND THE MEDIVATOR¿S ADVANTAGE PLUS PASS THROUGH AUTOMATIC ENDOSCOPY REPROCESSOR (AER). THE CORRECT REPROCESSING METHOD PER THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED IN THE IN-SERVICE. CUSTOMER MANAGER WAS PROVIDED WITH A COPY OF THE DOCUMENTATION OF THE IN-SERVICE, POSTERS, AND WEBSITES FOR REPROCESSING VIDEOS. THE DEVICE IS RETURNED AND AN EVALUATION COMPLETED FOR IT. THE USER¿S COMPLAINT WAS CONFIRMED. UPON INSPECTION AND TESTING, IT WAS OBSERVED THAT THERE WAS YELLOW DEBRIS AT THE SUCTION CYLINDER. THE UP/DOWN KNOB HAD LOOSE TENSION. THE OBJECTIVE LENS, LIGHT GUIDE (LG) LENS, LG BUNDLE AND BENDING CONTROL UNIT (BCU) WERE ALL OKAY. DEVICE WAS REPAIRED, INCLUDING SUCTION CYLINDER REPLACEMENT, AND RETURNED TO CUSTOMER. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.
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, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO A DIFFERENCE IN THE HANDLING OF EQUIPMENT AND RECOGNITION OF THE REPROCESSING PROCEDURE BETWEEN OLYMPUS' RECOMMENDATIONS AND THE FACILITY IN QUESTION. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: CHAPTER 5 5.5 MANUAL CLEANING IMMERSE A CLEAN 30 ML SYRINGE IN THE WATER AND FLUSH THROUGH THE WHITE FLUSHING PORT, AS FOLLOWS: A) BEFORE ATTACHING THE SYRINGE TO THE WHITE FLUSHING PORT (SO THAT YOU DO NOT PULL AIR INTO THE SYRINGE THAT MIGHT BE INSIDE THE FLUSHING TUBE), SLOWLY PULL THE SYRINGE PLUNGER TO FILL THE SYRINGE WITH WATER; B) ATTACH IT TO THE WHITE FLUSHING PORT OF THE DISTAL-END FLUSHING ADAPTER; C) THEN FORCEFULLY FLUSH THE DISTAL END WITH 30 ML OF WATER. CHAPTER 5 5.3 PRECLEANING ASPIRATE WATER FOR 30 SECONDS OR MORE, AS FOLLOWS: A) DEPRESS AND HOLD THE SUCTION VALVE (MH-443) ON THE ENDOSCOPE. B) WHILE DEPRESSING THE SUCTION VALVE, MOVE THE ELEVATOR CONTROL LEVER IN EACH DIRECTION THREE TIMES TO MOVE THE FORCEPS ELEVATOR UP AND DOWN. CHAPTER 7 WARNING IF USING AN OLYMPUS OER-AW OR OER-PRO, ENSURE THAT THE DISTAL END¿S INSTRUMENT CHANNEL OUTLET IS OPEN. IF CLOSED, OPEN THE INSTRUMENT CHANNEL OUTLET BY MOVING THE ELEVATOR CONTROL LEVER AS SHOWN BELOW UNTIL THE FORCEPS ELEVATOR STOPS. THEN, ATTACH THE DEDICATED CONNECTING TUBE TO THE ENDOSCOPE¿S DISTAL END, AND SET IN YOUR OER-AW OR OER-PRO ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, CONCERN WAS RAISED FOR THE REPROCESSING ACROSS MULTIPLE CUSTOMER SITES UPON FINDINGS AFTER DEVICES WERE INSPECTED WITH A BORESCOPE. THE BORESCOPE WAS PUT IN THE DEVICE BACKWARD THROUGH THE SUCTION CONNECTOR (CHRISTMAS TREE TYPE) ON THE SCOPE CONNECTOR AND ALL OF THE WAY UP WHERE THE UMBILICAL CORD MEETS THE CONTROL BODY. IT WAS OBSERVED THAT THE BRUSHES DID NOT TOUCH THE CHANNEL WALL ON THE SIDE THAT THE DEBRIS IS BEING FOUND. THE FINDINGS OF A BORESCOPE INSPECTION FOR THIS DEVICE ARE SMALL AMOUNT OF DEBRIS OBSERVED AT THE JUNCTION OF SUCTION CHANNEL AND UNIVERSAL CORD. IN ADDITION, AS OBSERVED DURING REPROCESSING, THE DIAL LOCK WOULD NOT STAY LOCKED AND THE INSTRUMENT CHANNEL HAD AN UNSPECIFIED MINOR ISSUE. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2371837 | EVIS EXERA III DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q190V | 04953170452024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |