BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1983794 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00557
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 17, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). FEEDER SHOE. THE DEVICE WAS RETURNED FOR ANALYSIS IN GOOD VISUAL CONDITION. AN ATTEMPT TO FIRE THE DEVICE WAS MADE AND THE DEVICE WOULD NOT FEED THE CLIPS. THE DEVICE WAS DISASSEMBLED TO EXAMINE THE CONDITION OF THE INTERNAL COMPONENTS AND THE FEEDER SHOE DRIVE TAB WAS NOTED TO BE DAMAGED, 15 CLIPS WERE FOUND REMAINING ON THE CLIP TRACK. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FINDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP WAS MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U360

    Patients

    Seq Age Sex Outcome Treatment
    1