BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 8058686 · Received November 11, 2018

    Report

    Report Number
    9612501-2018-01977
    Event Type
    Malfunction
    Date Received
    November 11, 2018
    Report Date
    December 27, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    UDI-DI
    10884521057852
    PMA / PMN Number
    K100242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE HANDLE WAS FLACCID AND NOT ATTACHED TO THE INTERNAL COMPONENTS. THE INSTRUMENT WAS DISMANTLED FOR VISUALIZATION OF INTERNAL COMPONENTS WHICH REVEALED THAT THE WISHBONE LINK WHICH ATTACHES THE TRIGGER TO THE FIRING MECHANISM HAD DISENGAGED. THE WISHBONE LINK WAS REATTACHED TO THE TRIGGER HANDLE AND THE INSTRUMENT WAS REASSEMBLED. THE INSTRUMENT WAS THEN FOUND TO CYCLE WITHOUT BINDING. FOURTEEN CLIPS LOADED INTO THE JAWS, FORMED PROPERLY, RELEASED FROM THE JAWS AND REMAINED SECURELY ATTACHED TO TEST MEDIA. WHEN THE CARTRIDGE WAS EMPTY, THE INTERLOCK ENGAGED TO PREVENT THE JAWS FROM APPROXIMATING. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE DISENGAGED WISHBONE LINK CONDITION MAY OCCUR IF THE HANDLE IS FORCEFULLY PULLED OPEN PRIOR TO FULLY COMPLETING THE FULL HANDLE COMPRESSION. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A MEDIASTINOSCOPY PROCEDURE, AFTER THE APPLICATION OF THE SECOND CLIP, THE CLAMP GOT STUCK IN THE CLOSER POSITION. DESPITE OF AN ATTEMPT TO RESET, THE CLAMP HAS NOT OPENED. THE DEVICE COULD BE REMOVED WITHOUT ANY OBSERVED INCIDENT. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898083 ENDO CLIP III CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176630 J8E2082X 10884521057852

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR