BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3140379 · Received May 31, 2013

    Report

    Report Number
    3005075853-2013-02707
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 9, 2013
    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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ADDITIONAL INFORMATION: AFTER THE SURGEON FIRED THE DEVICE THE CLIPS WERE MALFORMED? THE FIRST CLIP WAS MALFORMED AND ETC. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FIRST. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? THE SURGEON CHECKED THE LIGAMAX OUTSIDE THE PATIENT AT THE FIRST FIRING. 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? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? WERE ANY UNEXPECTED NOISES HEARD? NO. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? 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 CYCLED AND SEVEN CLIPS WITH GAP WERE FED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, NO ANOMALIES WERE FOUND. NO CONCLUSION COULD BE REACH AS TO WHAT MAY HAVE CAUSED THE INCIDENTS 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 DONOR NEPHRECTOMY PROCEDURE, THE OR TEAM OPENED FOR THE SURGEON A NEW LIGAMAX BUT THE CLIPS WERE DISTORTED SO THEY HAD TO OPEN NEW LIGAMAX. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242155 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C4OF

    Patients

    Seq Age Sex Outcome Treatment
    1