BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2033259 · Received March 30, 2011

    Report

    Report Number
    3005075853-2011-01265
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NO OPENING ISSUES WERE NOTED DURING EVALUATION; THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. 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, THE DEVICE WAS USED TO CLIP THE ARTERY AND IT HAD TO BE PULLED OFF THE BLOOD VESSEL AS IT DID NOT OPEN BACK UP PROPERLY. THEY USED ANOTHER CLIP APPLIER TO CONTROL THE BLEEDING AND COMPLETE THE PROCEDURE. NO MEASUREABLE AMOUNT OF BLOOD WAS LOST. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4302P

    Patients

    Seq Age Sex Outcome Treatment
    1