BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2110996 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02235
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; ONE PEAR SHAPED CLIP WAS RELEASED. UPON FIRING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS UNDER TRAVELED. THE ORANGE VISUAL INDICATOR IS A MECHANISM IN THE HANDLE OF THE DEVICE THAT SHOWS "ORANGE" WHEN THE DEVICE HAS EXHAUSTED ITS CLIPS. POTENTIAL CAUSES OF AN UNDER TRAVELED ORANGE VISUAL INDICATOR MAY BE: THE INDICATOR WHEEL IN THE HANDLE OF THE DEVICE MAY BECOME TEMPORARILY DISENGAGED DUE TO A DIMENSIONAL SHIFT OF MULTIPLE COMPONENTS INVOLVED ALLOWING TWO COMPONENTS TO SLIP PAST ONE ANOTHER; HIGHER THAN NORMAL FRICTION OF THE MECHANISM MAY CAUSE ONE OR MORE PARTS TO TEMPORARILY STICK. PLEASE NOTE THE UNDER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE DEVICE JAMMED ON THE INITIAL FIRING. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1