BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2143226 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02672
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH TWO CARTRIDGE RELOADS PRESENT. RELOAD A WAS RECEIVED FULLY FIRED AND RELOAD B WAS RECEIVED UNFIRED AND WITH THE SWING TAB IN THE UNLOCKED POSITION. THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE RELOAD B AND IT FIRED, CUT, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE DEVICE FIRED WITH NO DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND 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 WHIPPLE PROCEDURE, THE DEVICE WAS FIRED ACROSS THE STOMACH. AFTER FIRING, IT WAS NOTICED THAT THE DEVICE HAD ONLY FIRED ONE ROW OF STAPLES ON EACH SIDE. THE STAPLES THAT WERE DEPLOYED DID NOT CLOSE ALL THE WAY. THEY WERE IN THE SHAPE OF A GOAL POST. A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4RZQH

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE