BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 7673234 · Received July 10, 2018

    Report

    Report Number
    9612501-2018-01266
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 22, 2018
    Report Date
    October 4, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    UDI-DI
    20884521057859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF 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. TEN 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. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. 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 WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 LAPAROSCOPIC CHOLECYSTECTOMY, AFTER SOME FIRINGS, THE DEVICE WOULD NOT LOAD THE CLIP INTO THE JAWS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518399 ENDO CLIP III CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176630 J7L2148X 20884521057859

    Patients

    Seq Age Sex Outcome Treatment
    1