BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1905553 · Received November 23, 2010

    Report

    Report Number
    3005075853-2010-06650
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 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). THE ANALYSIS RESULTS FOUND THAT DEVICE (A) 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 CLIP AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE ANALYSIS RESULTS OF DEVICE (B) FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING THE JAWS REMAIN IN THE CLOSED POSITION, 1 PEAR SHAPED CLIPS WAS RELEASED DUE TO AND ADVANCER BYPASS, THE REMAINING 4 CLIPS WERE FIRED CONFORMING. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. AS NOT ENOUGH INFORMATION ABOUT THE INCIDENT REPORTED WAS AVAILABLE, THE EVENT COULD NOT BE CONFIRMED. BATCH # G9KK3Z, MFG DATE: 07/16/2010; EXP DATE: 06/16/2015. 3500A CODES: (B)(4): ADVANCER BYPASS - MALFORMED CLIP - JAWS CLOSED. 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 LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, JAMMING OCCURRED AND THE DEVICE COULD NOT BE USED. 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