BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1915171 · Received December 6, 2010

    Report

    Report Number
    3005075853-2010-06880
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BROKEN JAWS THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE JAWS BROKEN. UPON FUNCTIONAL TESTING OF THE DEVICE, THE CLIPS WERE EJECTED DUE TO THE FOUND CONDITION OF THE JAW. THE DEVICE LOCKED AS INTENDED BUT THE ORANGE INDICATOR DID NOT SHOW UP COMPLETELY. THE FOUND ORANGE INDICATOR FAILURE IS NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE JAW WAS BROKEN, BUT COULD BE REMOVED. THE PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1