BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3161534 · Received June 11, 2013

    Report

    Report Number
    3005075853-2013-02915
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 15, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WERE THE JAWS OF THE DEVICE ON TISSUE? ---NO. HOW WAS THE DEVICE REMOVED FROM TISSUE? WAS THERE ANY TISSUE DAMAGE? ---NO. IF SO EXPLAIN HOW THE DAMAGED TISSUE WAS REPAIRED? AT WHAT FIRING DID THIS OCCUR? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THERE ANY TORQUING OR TWISTING WHEN FIRING THE DEVICE? ---NO. WERE THERE ANY UNUSUAL NOISES HEARD? ---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 THREE CLIPS WITH GAP WAS 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 LAPAROSCOPIC CHOLECYSECTOMY PROCEDURE, THE JAWS COULD NOT BE OPENED ALL THE WAY WHEN THE DEVICE WAS USED FOR THE BLOOD VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262271 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C976

    Patients

    Seq Age Sex Outcome Treatment
    1