BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2123033 · Received June 14, 2011

    Report

    Report Number
    3005075853-2011-02405
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 24, 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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOR THE DEVICE FOUND THAT IT WAS RETURNED WITH THE LEFT CAM RAMP BROKEN MAKING THE INSTRUMENT NON-FUNCTIONAL. POSSIBLE CAUSES FOR THE CONDITION FOUND MIGHT BE TWISTING OF THE JAWS, FORCE PLACED ON THE JAWS DURING ACTIVATION OR EXCESSIVE LOADING DUE TO FORMING A CLIP OVER ANOTHER DEVICE EXCEEDING THE STRUCTURAL CAPABILITY OF THE JAWS AND/OR CAM. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE BROKEN CAM ISSUES. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GALLE PROCEDURE, AFTER FIRING OF THE FIRST CLIP THE SURGEON COULDN´T OPEN THE JAW - NO CLIP. THE SURGEON TRIED MORE OFTEN BUT HE COULDN´T FIRING A CLIP. HE OPENED A NEW DEVICE FOR FINISHING THE SURGERY. THERE WERE NO 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 C4DM1W

    Patients

    Seq Age Sex Outcome Treatment
    1