EVIS EXERA II COLONOVIDEOSCOPE
Report
- Report Number
- 8010047-2022-11827
- Event Type
- Malfunction
- Date Received
- July 13, 2022
- Report Date
- May 14, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDF
- UDI-DI
- 04953170237294
- PMA / PMN Number
- K100584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CUSTOMER INDIANA UNIV HEALTH (IU HEALTH) FACILITIES HAD CONCERNS CONNECTED WITH FINDINGS OF DEVICES INSPECTED BY BORESCOPE AND THE REPROCESSING AT THE VARIOUS IU HEALTH FACILITIES. ARISING FROM THE FINDINGS, DEVICES/EVENTS HAVE BEEN IDENTIFIED FOR THE IU HEALTH FACILITIES BELOW: INDIANA UNIVERSITY HLTH BEDFORD INC. INDIANA UNIVERSITY HEALTH BLOOMINGTON INC. BLOOMINGTON ENDOSCOPY CENTER LLC (BEC) INDIANA UNIV 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 INDIANA UNIV HEALTH MORGAN HOSPITAL INC. ARE AS BELOW: PATIENT IDENTIFIER MODEL # SERIAL NUMBER (B)(6) CF-HQ190L (B)(4). (B)(6) PCF-H190L (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) PCF-H180AL (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) GIF-1TQ160 (B)(4). 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 DOES NOT ALWAYS USE THE AIR/WATER CHANNEL CLEANING ADAPTER DURING THE PRE-CLEANING. THE CUSTOMER LEAK TESTS THE SCOPE FOR ONLY 10 SECONDS AND DOES NOT ANGULATE THE CONTROL KNOBS. CUSTOMER DOES NOT REMOVE THE SCOPE FROM THE WATER PRIOR TO REMOVING THE LEAK TESTER FROM THE SCOPE CONNECTOR. THE SCOPE CONNECTOR IS THE ONLY PART REMOVED FROM THE WATER. THE LEAK TESTER IS ONLY DISCONNECTED FROM THE ETHYLENE OXIDE (EO OR ETO) ETO VALVE ON THE SCOPE AND IS NOT TURNED OFF OR PULLED FROM THE MU-1 UNIT TO DEPRESSURIZE THE SCOPE. 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 FROM MEDIVATORS. 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 DSD 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. CUSTOMER WAS ADVISED TO FOLLOW ALL VALIDATED REPROCESSING METHODS LISTED IN THE REPROCESSING IFU. THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME.
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, IT¿S LIKELY THERE WAS DEBRIS IN THE SUCTION TUBE DUE TO THE BRUSH NOT TOUCHING ALL AREAS OF THE CHANNEL. ADDITIONALLY, IT¿S LIKELY THAT INCORRECT REPROCESSING OCCURRED BECAUSE THE USER¿S UNDERSTANDING DIFFERED FROM OLYMPUS RECOMMENDATION. THE ROOT CAUSE OF THE DEBRIS IN SUCTION TUBE, BRUSH NOT TOUCHING ALL AREAS IN THE CHANNEL, AND INCORRECT REPROCESSING WAS UNABLE TO BE IDENTIFIED. THE OCCURRENCE OF THE REPORTED PROBLEM CAN BE PREVENTED BY ADHERING TO THE INSTRUCTIONS FOR USE (IFU). THE CUSTOMER DOES NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU) IN THE FOLLOWING OBSERVATIONS MADE BY ENDOSCOPY SUPPORT SPECIALIST (ESS): 1) THE CUSTOMER DOES NOT ALWAYS USE THE AIR/WATER CHANNEL CLEANING ADAPTER DURING THE PRE-CLEANING. IFU WARNS AS FOLLOWS: ¿TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AW (AIR/WATER) CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE.¿ 2) THE CUSTOMER LEAK TESTS THE SCOPE FOR ONLY 10 SECONDS AND DOES NOT BEND THE BENDING SECTION. THE STEPS OF LEAKAGE TEST ARE DETAILED IN THE IFU AT SECTION 5.4 ¿LEAKAGE TESTING OF THE ENDOSCOPE¿ AS FOLLOWS: ¿WITH THE LEAKAGE TESTER ATTACHED, IMMERSE THE ENDOSCOPE IN THE WATER AND OBSERVE FOR APPROXIMATELY 30 SECONDS WHILE DEFLECTING THE BENDING SECTION OF THE ENDOSCOPE BY TURNING THE ENDOSCOPE¿S UP/DOWN AND RIGHT/LEFT ANGULATION CONTROL KNOBS. CONFIRM THAT THERE IS NO LOCATION ON THE ENDOSCOPE FROM WHICH A CONTINUOUS SERIES OF AIR BUBBLES EMERGES.¿ 3) THE CUSTOMER DOES NOT REMOVE THE SCOPE FROM WATER PRIOR TO DETACHING THE LEAK TESTER FROM THE SCOPE. THE SCOPE CONNECTOR IS THE ONLY PART REMOVED FROM THE WATER. THE STEPS OF LEAKAGE TEST ARE DETAILED IN SECTION 5.4 ¿LEAKAGE TESTING OF THE ENDOSCOPE¿ AS FOLLOWS: ¿REMOVE THE ENDOSCOPE FROM THE WATER WITH THE LEAKAGE TESTER STILL ATTACHED.¿ 4) THE CUSTOMER DOES NOT TURN OFF MAINTENANCE UNIT (MU-1) BEFORE DETACHING THE LEAK TESTER FROM THE SCOPE. THE STEPS OF LEAKAGE TEST ARE DETAILED AT ¿5.4 LEAKAGE TESTING OF THE ENDOSCOPE¿ AS FOLLOWS: ¿DETACH THE LEAKAGE TESTER FROM THE MAINTENANCE UNIT (MU-1) BEFORE DETACHING THE LEAKAGE TESTER FROM THE ENDOSCOPE. IF THE LEAKAGE TESTER IS DETACHED FROM THE ENDOSCOPE BEFORE DETACHING THE LEAKAGE TESTER FROM THE MAINTENANCE UNIT, THE AIR PRESSURE INSIDE THE ENDOSCOPE WILL NOT VENT PROPERLY. THIS MAY DAMAGE THE ENDOSCOPE.¿ 5) THE CUSTOMER DOES NOT FOLLOW THE CORRECT BRUSHING ORDER DURING MANUAL CLEANING. BRUSHING STEPS ARE DETAILED IN SECTION 5.5 ¿MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES BRUSH THE CHANNELS¿. 6) THE CUSTOMER DOES NOT WIPE THE SCOPE DOWN AFTER FLUSHING WITH DETERGENT SOLUTION AND DOES NOT LET IT SOAK FOR THE DETERGENT MANUFACTURER'S RECOMMENDED TIME. THE IFU STATES ¿DRY EXTERNAL SURFACES: DRY THE EXTERNAL SURFACES OF THE ENDOSCOPE, THE CHANNEL PLUG, THE INJECTION TUBE, AND THE AUXILIARY WATER TUBE BY WIPING WITH CLEAN LINT-FREE CLOTHS.¿ ALSO, SECTION 5.5 STATES ¿MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES FILL A CLEAN, LARGE BASIN WITH THE DETERGENT SOLUTION AT THE TEMPERATURE AND CONCENTRATION RECOMMENDED BY THE DETERGENT MANUFACTURER.¿ 7) THE SCOPE IS NOT SOAKED AND GOES DIRECTLY INTO THE RINSE SINK. ¿5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES FILL A CLEAN, LARGE BASIN WITH THE DETERGENT SOLUTION AT THE TEMPERATURE AND CONCENTRATION RECOMMENDED BY THE DETERGENT MANUFACTURER.¿ 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 FINDINGS OF A BORESCOPE INSPECTION FOR THIS DEVICE ARE METAL DAMAGE ON INSTRUMENT CHANNEL, STAINING ON BIOPSY PORT, DEBRIS AND SEDIMENT AT THE UNIVERSAL CORD, AND BLACK STAINING IN INSTRUMENTAL CHANNEL. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701356 | EVIS EXERA II COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | FDF | AIZU OLYMPUS CO., LTD. | PCF-H180AL | 04953170237294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |