BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 6700057 · Received July 11, 2017

    Report

    Report Number
    8010047-2017-00851
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 14, 2017
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    PMA / PMN Number
    PK980465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC). CONSEQUENTLY, OMSC COULD NOT EVALUATE THE DEVICE. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, SINCE OMSC COULD NOT EVALUATE THE DEVICE. SINCE THE MANUFACTURING LOT NUMBER WAS UNKNOWN, THE ALL ITEM OF DEVICE HISTORY RECORDS FOR ONE YEAR PERIOD PRIOR TO THE INCIDENT WERE REVIEWED WITH NO IRREGULARITIES NOTED. BASED ON THE SIMILAR CASES IN THE PAST, IT WAS KNOWN THAT THE USER MIGHT BE UNABLE TO RELEASE THE LOOP BECAUSE THE LOOP WAS CAUGHT BETWEEN THE HOOK AND THE COIL SHEATH AFTER THE LOOP WAS RELEASED IN THE TUBE SHEATH FOR AN UNSPECIFIED REASON. THE INSTRUCTION MANUAL OF THE DEVICE HAS ALREADY WARNED AS FOLLOWS; WARNING: DO NOT REMOVE THE LOOP FROM THE HOOK WHILE THE COIL SHEATH IS NOT EXTENDED FROM THE TUBE SHEATH. OTHERWISE, THE LOOP MAY BE TANGLED WITH THE HOOK AND BECOME IMPOSSIBLE TO BE REMOVED.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING AN AMPUTATION OF POLYP. DURING USE, THE LOOP WAS CLAMPED AND SERPENTINE IN THE TUBE SHEATH. AS A RESULT, IT WAS NOT POSSIBLE TO LOOSE AND REMOVE THE LOOP FROM THE POLYP. THE OPERATORS HAD NO LOOP CUTTER IN THE OPERATION ROOM. THE OPERATORS AMPUTATED THE POLYP BIT BY BIT USING ARGON-PLASMA-COAGULATION UNTIL IT WAS POSSIBLE TO REMOVE THE LOOP WITH THE TUBE SHEATH OUT OF THE PATIENT.THE PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE AND AN UNCERTAIN ARGON-PLASMA-COAGULATION DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484553 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1