BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3120341 · Received May 20, 2013

    Report

    Report Number
    3005075853-2013-02418
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 24, 2013
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. THE DEVICE PRODUCES A SOUND WHILE BEING FIRED OUT. THIS SOUND IS GENERATED BY INTERNAL MOVEMENTS ON THE HANDLE OF THE DEVICE, AND IT MAY VARY IN VOLUME DEPENDING ON THE CONDITION OF THE INTERNAL COMPONENTS, HOWEVER LOWER VOLUME IS NOT AN INDICATION OF DEVICE FAILURE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUESTS FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE JAWS OF THE CLIPPER WAS NOT OPENING UP COMPLETELY AND THAT WHEN THE CLIP WAS BEING APPLIED THE PRODUCT WAS NOT MAKING THE USUAL CLICKING SOUND. ANOTHER DEVICE WAS THEN USED AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221781 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CP42

    Patients

    Seq Age Sex Outcome Treatment
    1