BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** CLIP APPLIER - MEDIUM - 19 CM

    MDR report key: 3790759 · Received May 5, 2014

    Report

    Report Number
    1527736-2014-00013
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE CLIPS WERE NOT LOADING PROPERLY INTO THE JAWS (FORMING A "J" ON ONE LEG). THEY ALSO WE'RE NOT RELEASING FROM THE JAWS AFTER FORMING. LASTLY, THE APPLIER JAWS WERE NOT ALWAYS RETURNING TO THEIR OPEN POSITION AFTER DEPLOYMENT OF THE CLIPS. THE ANALYSIS RESULTS FOUND THAT THE LC407 DEVICE WAS RECEIVED WITH THE HANDLE COATING DAMAGED AND JAWS WERE MISALIGNED; THEREFORE, THE CLIPS COULD NOT BE LOADED INTO THE JAWS. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE THE DEVICE DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267563 LIGACLIP** CLIP APPLIER - MEDIUM - 19 CM REUSABLE CLIP APPLIERS GDO ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1