BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 45MM

    MDR report key: 3173399 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03080
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC BYPASS PROCEDURE, ON ABOUT THE THIRD FIRING ON THE STOMACH USING A GREEN CARTRIDGE THE GUN DURING THE FIRING CYCLE STARTED TO PUSH THE TISSUE BUNCHING IT UP. IT WAS ABOUT A THIRD OF THE WAY INTO THE FIRING CYCLE AND THEY STOPPED AND REVERSED THE BLADE. THEY DID COMPLETE THE CASE WITH A BLACK CARTRIDGE IN SAME GUN THERE WERE NO PATIENT CONSEQUENCES. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274081 PWRD ECH FLEX 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1