BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 9739413 · Received February 21, 2020

    Report

    Report Number
    9612501-2020-00319
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 31, 2020
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GDO
    UDI-DI
    10884521047266
    PMA / PMN Number
    K071406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 AND THAT THE JAWS WERE LOCKED IN THE CLAMPED POSITION. 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 JAWS OF THE INSTRUMENT THEN REOPENED, AND IT WAS NOTED THAT NO CLIPS REMAINED IN THE INSTRUMENT. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE 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 DUE TO THE PRODUCT NOT BEING USED AS INTENDED 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.

    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 AT FIRST THEY WERE PERFORMING FIRING WITHOUT PROBLEMS, BUT WHEN THE DEVICE WAS INSERTED VIA A TROCAR HALFWAY, THE JAWS NO LONGER OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203622 ENDO CLIP III APPLIER, SURGICAL, CLIP GDO DAVIS & GECK CARIBE LTD 176630B 10884521047266

    Patients

    Seq Age Sex Outcome Treatment
    1