BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 1900563 · Received November 16, 2010

    Report

    Report Number
    3005075853-2010-06554
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INSTRUMENT B: BATCH # (B)(4) ; EXP DATE: (B)(6) 2015; (B)(6) 2010 THE ANALYSIS RESULTS OF THE EL5ML DEVICE (A) 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 TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING THE CONSECUTIVE FIRING SEQUENCES CAUSING THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES; PEAR SHAPED CLIPS WERE RELEASED. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE ADVANCER BYPASS AND OPENING ISSUES. DURING THE NEXT FIRING SEQUENCE THE CLIP WAS FORMED AS CONFORMING. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR DID NOT SHOW UP. AS NOT ENOUGH INFORMATION ABOUT THE INCIDENT REPORTED WAS AVAILABLE, THE EVENT COULD NOT BE CONFIRMED. THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE (B) 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 DID NOT SHOW UP COMPLETELY. THIS FINDING IS NOT RELATED WITH THE EVENT REPORTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TWO CLIPS CAME OUT TOGETHER AND THE CLIPS ARE LOOSE. NO TISSUE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4TJ7J

    Patients

    Seq Age Sex Outcome Treatment
    1