BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE DISTAL ATTACHMENT

    MDR report key: 19900881 · Received August 2, 2024

    Report

    Report Number
    9614641-2024-01565
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    June 24, 2024
    Report Date
    October 25, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K984358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED: H3. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED MALFUNCTION WAS NOT REPRODUCED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU). DO NOT USE VASELINE (OR ANY LUBRICANT THAT CONTAINS PETROLEUM JELLY), OLIVE OIL, ALCOHOL OR THE XYLOCAIN SPRAY TO LUBRICATE THE INSTRUMENT. DOING SO, COULD CAUSE EQUIPMENT DAMAGE OR CAUSE THE INSTRUMENT TO FALL OFF OF THE ENDOSCOPE INSIDE THE PATIENT. WHEN ATTACHING THIS PRODUCT, MAKE SURE THAT ANY ALCOHOL USED TO CLEAN THE ENDOSCOPE HAS DRIED. ALSO, DO NOT USE VASELINE (MEDICINES CONTAINING VASELINE), OLIVE OIL, ALCOHOL OR XYLOCAINE SPRAY DIRECTLY ON THE ENDOSCOPE. THIS MAY RESULT, IN DAMAGE TO THE DEVICE OR THE PRODUCT FALLING OFF. BE SURE TO WIPE AWAY ANY EXCESS LUBRICANT BEFORE MOUNTING THE INSTRUMENT. AND SECURE THE INSTRUMENT FIRMLY, USING MEDICAL TAPE WITH SUFFICIENT ELASTICITY. IF THE INSTRUMENT IS NOT FIRMLY SECURED, IT COULD COME OFF INSIDE THE BODY CAVITY, DURING USE AND CAUSE PATIENT INJURY, SUCH AS MUCOUS MEMBRANE DAMAGE. PLEASE WIPE OFF ANY EXCESS LUBRICANT. AND SECURELY ATTACH THE PRODUCT WITH ELASTIC MEDICAL TAPE. IF THE TAPE IS NOT SECURELY ATTACHED, THE PRODUCT MAY FALL OFF, DURING USE. USE THIS INSTRUMENT ONLY IN COMBINATION WITH PRODUCTS RECOMMENDED BY OLYMPUS. IF COMBINED WITH PRODUCTS NOT RECOMMENDED BY OLYMPUS, THE INSTRUMENT MAY FALL OFF OF THE ENDOSCOPE INSIDE THE PATIENT AND MAY CAUSE MALFUNCTION OR EQUIPMENT DAMAGE. PLEASE USE THIS PRODUCT IN COMBINATION WITH THE RELATED PRODUCTS SHOWN BELOW. IF USED IN ANY OTHER COMBINATION, IT MAY FALL INTO THE BODY CAVITY, THE PRODUCT MAY BE DAMAGED AND FUNCTIONALITY MAY NOT BE GUARANTEED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DISTAL ATTACHMENT CAP FELL OF INSIDE THE PATIENT¿S BODY. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371943 DISPOSABLE DISTAL ATTACHMENT DISPOSABLE DISTAL ATTACHMENT FDS AOMORI OLYMPUS CO., LTD. D-206-05 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other