BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1790251 · Received August 10, 2010

    Report

    Report Number
    3005075853-2010-04538
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE (B)(4) 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 VISIBLE AT 14TH FIRING SEQUENCE THUS, IT WAS NOT COMPLETELY VISIBLE. THIS FINDING IS NOT RELATED TO THE EVENT REPORTED. 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 A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE HAD BEEN FIRED TWO OR THREE TIMES THEN IT WOULD NOT OPEN TO FIRE AGAIN. IT IS UNKNOWN IF THE DEVICE WAS CLOSED ON TISSUE. IT IS UNKNOWN HOW IT WAS REMOVED / OPENED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4T458

    Patients

    Seq Age Sex Outcome Treatment
    1