BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FZP CLIP, IMPLANTABLE

    MDR report key: 1476420 · Received June 18, 2009

    Report

    Report Number
    3005075853-2009-03628
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 26, 2009
    Report Date
    June 15, 2009
    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
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. EVALUATION SUMMARY: THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE SURGEON OPENED THE LIGAMAX DEVICE AND SECURED CLIPS ONTO THE CYSTIC DUCT. ON THE SECOND FIRING OF THE DEVICE, THE JAWS OF THE CLIP APPLIER GOT STUCK AND COULD NOT BE PRYED OPEN. THE SURGEON OPENED A SECOND LIGAMAX DEVICE TO RELEASE THE STUCK DEVICE FROM THE CYSTIC DUCT AND REMOVE THE DEVICE OUT OF THE PT. THE SURGEON COMMENTED THAT THIS WAS A TECHNICAL PROBLEM WITH THE LIGAMAX DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FZP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA F4N43M

    Patients

    Seq Age Sex Outcome Treatment
    1