BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1770800 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04231
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 1, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE WAS RECEIVED 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. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS OVER TRAVELED. THIS FINDING IS NOT RELATED TO THE EVENT REPORTED. ALTHOUGH, NO OPENING ISSUES WERE NOTED DURING TESTING, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL CAUSE OF THE OPENING ISSUES. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WILL NOT COME OFF STANDBY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE TRIGGER BECAME NOT TO RETURN TO THE HOME POSITION AUTOMATICALLY AFTER A FEW FIRINGS. THE TRIGGER WAS RETURNED TO THE HOME POSITION BY HAND. THE FIRED CLIPS WERE FORMED PROPERLY. THEN, AS THE DEVICE WAS REMOVED FROM THE PATIENT AND TEST-FIRED WITHOUT TISSUE OUTSIDE THE PATIENT, NO CLIPS REMAINED IN THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    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