BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 18828594 · Received March 4, 2024

    Report

    Report Number
    9610595-2024-04478
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    January 30, 2024
    Report Date
    May 8, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170343360
    PMA / PMN Number
    K112680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE CUSTOMER IS CURRENTLY BEING PERFORMED. AFTER CULTURE TESTING, THE DEVICE WILL BE EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    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, RESULTS OF THIRD-PARTY TESTING, THE DEVICE EVALUATION, THE LMS FINAL INVESTIGATION AND TO ADD THE B3 FIELD. THE LM REVIEWED THE CUSTOMER PROVIDED CDS PROCESSES WHERE THE FOLLOWING DEVIATION FROM THE IFU WAS CONFIRMED: WATER FILTER OF THE REPROCESSOR WAS NOT REPLACED PERIODICALLY. THE USER FACILITY PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: AW-CHANNEL. CFU: RASEN. BACTERIAL IDENTIFICATION: KNS, AS. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: AW-CHANNEL. CFU: 20 CFU. BACTERIAL IDENTIFICATION: KNS. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: BIOPSY/SUCTION CHANNEL. CFU: 1CFU. BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS. THE DEVICE WAS EVALUATED WHERE AN ADDITIONAL POTENTIAL ADVERSE EVENT WAS NOTED WHERE FOREIGN MATERIAL REMAINED IN THE AIR/WATER CHANNEL AND AIR/WATER CYLINDER. 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 DEVIATION FROM IFU WAS CONFIRMED, THEREFORE REPROCESSING MAY HAVE BEEN CONDUCTED INSUFFICIENTLY; HOWEVER, THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED NOR THE ROOT CAUSE OF WHY IT REMAINED. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU "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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178286 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-1TH190 04953170343360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown