BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 3832512 · Received May 27, 2014

    Report

    Report Number
    3005075853-2014-03546
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE FIRED THROUGH LOCKOUT THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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. IN ADDITION, THE LOCKOUT MECHANISM WAS FOUND TO BE NON FUNCTIONAL. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. 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 AN UNKNOWN PROCEDURE, STAPLE STUCK WHEN THE DOCTOR USED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311152 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1