BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP

    MDR report key: 7498531 · Received May 9, 2018

    Report

    Report Number
    1219930-2018-02518
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 27, 2018
    Report Date
    October 3, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    FZP
    UDI-DI
    10884521057876
    PMA / PMN Number
    K954435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH 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. MICROSCOPIC INSPECTION OF THE INSTRUMENT NOTED PRESENCE OF CLIPS IN THE TUBE. HOWEVER, IT WAS OBSERVED THAT THE PUSHER BAR WAS BUCKLED, AND THE RED INDICATOR WAS VISIBLE IN THE WINDOW. FUNCTIONAL EVALUATION COULD NOT BE PERFORMED AS THE SAFETY INTERLOCK FEATURE WAS ENGAGED. 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 BUCKLED PUSHER BAR CONDITION MAY OCCUR UNDER THE FOLLOWING CONDITIONS: 1) IF THE LOAD INDICATOR PRINTED ON THE DISTAL END OF THE INSTRUMENT SHAFT HAS NOT CLEARED THE DISTAL END OF THE CANNULA AND THE INSTRUMENT IS FIRED. 2) IF A HEAVY LOAD IS APPLIED TO THE SIDE OF THE JAW WHICH PARTIALLY CLOSES IT DURING THE CLIP LOADING PROCESS. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803IF 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, INTRA-OPERATIVELY, THE CLIPS JAMMED. THE CLIPS WERE NOT DISLODGED FROM THE DEVICE. THERE WAS A SMALL DELAY IN THE PROCEDURE SINCE THEY OPENED ANOTHER PRODUCT TO COMPLETE THE CASE. ALSO THE JAWS DID NOT CLOSE WHEN THE HANDLE WAS SQUEEZED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342378 ENDO CLIP CLIP, IMPLANTABLE FZP COVIDIEN LP LLC NORTH HAVEN 176620 N7E0195CX 10884521057876

    Patients

    Seq Age Sex Outcome Treatment
    1