BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 4102772 · Received September 19, 2014

    Report

    Report Number
    3005075853-2014-06532
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 31, 2014
    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
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = JAWS. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED WITH ONE JAW DISENGAGED FROM THE CAM; THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIPS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, ONE CLIP WAS EJECTED DUE TO THE JAW CONDITION. IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE, THE JAW WAS READJUSTED AND IN THE NEXT ACTUATIONS, SEVEN CONFORMING CLIPS WERE FED AND FORMED; FINALLY THE DEVICE LOCKED OUT AS INTENDED. POSSIBLE CAUSES FOR THE CONDITION OF THE JAW DISENGAGED FROM THE CAM MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. 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 AN UNKNOWN PROCEDURE, THREE DEVICES FAILED. IN THE SHOT MOMENT, TWO OR THREE EXTRA CAME OUT FROM THE SIDES AND THE DEVICE LOCKED. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583939 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4DR43

    Patients

    Seq Age Sex Outcome Treatment
    1