BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2233395 · Received September 2, 2011

    Report

    Report Number
    3005075853-2011-03637
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    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 AFFILIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY WHAT IS MEANT BY FORK FROM TIP? THE FIRED STAPLE LEG SPLIT. WAS THE DEVICE ABLE TO BE FIRED? YES. IF FIRED, WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? THE 1ST FIRING. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? UNKNOWN. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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 CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, FORK FROM TIP. 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-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1