BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1962581 · Received January 18, 2011

    Report

    Report Number
    3005075853-2011-00241
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 27, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAW. 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 LEFT JAW BECAME BROKEN DURING THE FIRST FIRING SEQUENCE. DUE TO THE CONDITION OF THE JAW THE REMAINING CLIPS WERE EJECTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE DEVICE WAS USED TO CLOSE THE POUCH WITH THE CHOLECYST INSIDE. WHEN THE DEVICE WAS FIRED ON THE THREAD OF THE POUCH, THE TRIGGER DID NOT RETURN TO THE HOME POSITION AND THE CLIP DID NOT COME OFF FROM THE JAW. WHEN THE DOCTOR GRASPED THE TRIGGER AGAIN, AN ABNORMAL SOUND WAS HEARD AND THE JAW WOULD NOT OPEN. AS THE FIRING WAS THE LAST FIRING IN THIS PROCEDURE, THE OPERATION WAS FINISHED WITHOUT USING ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE ORANGE INDICATOR WAS SHOWN. THE SALES REP EXPLAINED TO THE DOCTOR THAT THE JAW WOULD BE OPENED BY RETURNING THE TRIGGER BY HAND WHEN THE JAW WAS NOT OPENED.

    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