BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 1874535 · Received October 19, 2010

    Report

    Report Number
    3005075853-2010-05947
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. FIRED THROUGH THE LOCKOUT THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO HAVE THE LOCKOUT FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LAST CLIP LOCKOUT FEATURE DESIGNED TO INCREASE THE FORCE REQUIRED TO CLOSE THE TRIGGER, THEREBY REDUCING THE POSSIBILITY THAT THE EMPTY JAWS WILL BE CLOSED ON A VESSEL. IF THE TRIGGER IS FORCED CLOSED, ONCE THE LAST CLIP LOCKOUT HAS ENGAGED, THE JAWS MAY REMAIN CLOSED. 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 WOULD NOT DEPLOY ANY CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4T54W

    Patients

    Seq Age Sex Outcome Treatment
    1