BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 15022149 · Received July 14, 2022

    Report

    Report Number
    9610595-2022-00011
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Report Date
    January 19, 2023
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED 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 DISINFECTANT SOLUTION COUNTER ISSUE WAS CAUSED BY USER ERROR WITHOUT DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), REQUESTING ASSISTANCE WITH SETTING THE LCG USAGE CENTER OF THE ENDOSCOPE REPROCESSOR. IT WAS REPORTED, THE USER CHANGED THE LCG USAGE COUNTER, AND THE DISINFECTANT REPLACEMENT INDICATOR BLINKED CONSTANTLY EVEN AFTER CHANGING THE LCG. DURING TROUBLESHOOTING, USER WAS WALKED THROUGH THE STEPS TO RESET THE LCG USAGE COUNTER TO 35 CYCLES AND 5 DAYS. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402630 ENDOSCOPE REPROCESSOR ENDOSCOPE WASHER/DISINFECTOR FEB OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown