BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2013218 · Received March 10, 2011

    Report

    Report Number
    3005075853-2011-00965
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    October 6, 2010
    Report Date
    February 14, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER FIRED THROUGH LOCKOUT. THE DEVICE WAS RECEIVED WITH THE JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; NO CLIP WAS RELEASED. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LOCKOUT FEATURE THAT IS DESIGNED TO INCREASE THE REQUIRED FORCE IT TAKES TO CLOSE THE TRIGGER ONCE THE LAST CLIP HAS BEEN FIRED; THIS REDUCES THE POSSIBILITY OF EMPTY JAWS BEING CLOSED ON A STRUCTURE. IN ADDITION, IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, WHEN THE CLIP HAD TO BE POSITIONED ON THE CYSTIC ARTERY, THE APPLIER DIDN`T REOPEN; AS A CONSEQUENCE THERE WAS A DAMAGE ON THE CYSTIC ARTERY BUT THERE WASN`T A SERIOUS BLEEDING. IT WASN`T REQUIRED AN ACTION TO MANAGE THE PROBLEM BECAUSE THERE WAS ALREADY A CLIP APPLIED UPSTREAM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4TF60

    Patients

    Seq Age Sex Outcome Treatment
    1