BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2072879 · Received April 29, 2011

    Report

    Report Number
    3005075853-2011-01783
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    February 23, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCKOUT. THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RETURNED EMPTY AND WITH THE LOCK OUT MECHANISM BROKEN AS IT WAS FIRED THROUGH. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED; THEREFORE A POTENTIAL CAUSE OF THE CUSTOMER REPORTED EXPERIENCE IS THE FIRING OF ALL OF THE CLIPS AND THE INSTRUMENT "JAMMED" (ACTIVATION OF THE LOCK OUT MECHANISM). THE INSTRUMENT HAS AN ORANGE INDICATOR THAT APPEARS ON THE TOP OF THE HANDLE AS A REFERENCE FOR THE USER AS TO THE QUANTITY OF CLIPS REMAINING. 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 SINGLE SITE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE JAMMED AND ALL THE CLIPS WERE USED UP OUTSIDE OF THE PATIENT IN AN ATTEMPT TO GET THE DEVICE TO WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U045

    Patients

    Seq Age Sex Outcome Treatment
    1