BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2051364 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01466
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 16, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING FIVE CONSECUTIVE FIRING SEQUENCES CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; PEAR SHAPED CLIPS WERE RELEASED. THE NEXT THREE CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. DURING THE LAST FIVE FIRING SEQUENCES SCISSOR CLIPS WERE FED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, THE FEED CONNECTOR WELD WAS NOTED TO BE NOT PROPERLY ASSEMBLED CAUSING CLIP SHORT FED; THE JAWS GOT DISTORTED DURING THE FORMATION OF THE CLIPS CAUSING THE FOUND SCISSOR CLIPS. 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 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 CHOLECYSTECTOMY PROCEDURE THE DEVICE LOCKED ON THE CYSTIC DUCT. THE DEVICE WAS REMOVED WITHOUT ANY DAMAGE TO THE DUCT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    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