BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 7567508 · Received June 4, 2018

    Report

    Report Number
    9612501-2018-01062
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 17, 2018
    Report Date
    August 17, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GDO
    UDI-DI
    20884521047263
    PMA / PMN Number
    K071406
    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 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. ELEVEN 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 CONDITIONS. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THEY STOPPED USING THE DEVICE BECAUSE CLIPPING BECAME IMPOSSIBLE. THE JAWS WOULD NOT OPEN DURING USE. THE SURGEON OPENED THE HANDLE IN REVERSE AND THE JAWS OPENED. THEY USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409335 ENDO CLIP III APPLIER, SURGICAL, CLIP GDO DAVIS & GECK CARIBE LTD 176630B J7L2371X 20884521047263

    Patients

    Seq Age Sex Outcome Treatment
    1