BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1993927 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00667
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    December 13, 2010
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAW/CAM THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. THE DEVICE WAS CYCLED, FED AND PROPERLY FORMED THE CLIPS UPON FIRING. HOWEVER, DURING EACH FIRING SEQUENCE, THE TRIGGER HESITATED WHEN ATTEMPTING TO OPEN THE DEVICE. ALTHOUGH NO AID WAS REQUIRED TO OPEN THE TRIGGER, IT DID TAKE LONGER THAN USUAL (2-3 SECONDS) TO RETURN THE TRIGGER TO THE OPEN POSITION. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT COMPLETELY VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. THE DEVICE WAS CYCLED, FED AND PROPERLY FORMED THE CLIPS UPON FIRING. HOWEVER, DURING EACH FIRING SEQUENCE THE TRIGGER HESITATED WHEN ATTEMPTING TO OPEN THE DEVICE. ALTHOUGH NO AID WAS REQUIRED TO OPEN THE TRIGGER, IT DID TAKE LONGER THAN USUAL (2-3 SECONDS) TO RETURN THE TRIGGER TO THE OPEN POSITION. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT 11TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH #: G9L62M; MFG DATE: 10/05/2010; EXP DATE: 01/16/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE RECEIVED WITH A NOTE ON THE BOX STATING THEY MALFUNCTIONED. THEY DID NOT WORK PROPERLY. NO OTHER DETAILS OF THE EVENT ARE AVAILABLE. 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 G4U26U

    Patients

    Seq Age Sex Outcome Treatment
    1