BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 15007475 · Received July 13, 2022

    Report

    Report Number
    8010047-2022-11852
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Report Date
    May 10, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HLTH 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 INDIANA UNIVERSITY HEALTH PAOLI INC. ARE AS BELOW: PATIENT IDENTIFIER MODEL NUMBER SERIAL NUMBER (B)(6) CF-HQ190L (B)(4). (B)(6) PCF-H190DL (B)(4). (B)(6) PCF-H190DL (B)(4). (B)(6). GIF-H190 (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) CF-HQ190L (B)(4). THIS MEDWATCH IS FOR PATIENT IDENTIFIER: (B)(6). IN-SERVICE HAS BEEN SCHEDULED BY THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) TO OBSERVE THE FACILITY¿S REPROCESSING OF ENDOSCOPES. THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS SHIPPED IN ACCORDANCE WITH THE SPECIFICATIONS. BASED ON THE RESULTS OF THE INVESTIGATION, IT¿S LIKELY THE DEBRIS IN THE SUCTION TUBE WAS CAUSED BY THE THIRD-PARTY CLEANING BRUSH NOT TOUCHING ALL AREAS IN THE SUCTION CHANNEL. ADDITIONALLY, REPROCESSING WAS OBSERVED BY OLYMPUS PERSONNEL ON-SITE AND CONFIRMED DEVIATIONS FROM THE INSTRUCTIONS FOR USE (IFU). IT IS LIKELY THERE WAS A DIFFERENCE IN THE HANDLING OF EQUIPMENT AND RECOGNITION OF THE REPROCESSING PROCEDURE BETWEEN OLYMPUS' RECOMMENDATIONS AND THE FACILITY IN QUESTION. HOWEVER, A FINAL ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE OCCURRENCE OF THE REPORTED PROBLEM CAN BE PREVENTED BY ADHERING TO THE INSTRUCTIONS FOR USE (IFU) WHICH STATES THE FOLLOWING: ¿WIPE THE INSERTION SECTION TO ASPIRATE WATER. REMOVE THE ENDOSCOPE FROM THE WATER WITH THE LEAKAGE TESTER STILL ATTACHED. 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. THE PROPER BRUSHING ORDER IS MENTIONED AT 5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES, BRUSH THE CHANNELS. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER'S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

    Description of Event or Problem · 0

    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 GROSS DEBRIS FOUND AT THE JUNCTION OF SUCTION CHANNEL AND UNIVERSAL CORD. THE DEVICE WAS SOAKED FOR MORE THAN AN HOUR AND THEN BRUSHED. THE DEBRIS WAS STILL PRESENT. THE CUSTOMER THEN RAN A BRUSH DOWN THE UMBILICAL CORD AND THE BORESCOPE WAS PUT IN BACKWARDS. IT WAS OBSERVED THAT THE BRUSHES DID NOT TOUCH THE CHANNEL WALL ON THE SIDE THAT THE DEBRIS IS BEING FOUND. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407932 EVIS EXERA III COLONOVIDEOSCOPE FLEXIBLE VIDEO COLONOSCOPE, REUSABLE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown