BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 1950698 · Received January 6, 2011

    Report

    Report Number
    3005075853-2011-00065
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ATW35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A TR35W RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE RELOAD WAS LOADED ON THE DEVICE AS INTENDED AND WITHOUT ANY DIFFICULTIES NOTED AND DID NOT FELL OUT DURING FUNCTIONAL TESTING. 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 AN UNKNOWN PROCEDURE, THE DEVICE FAILED DURING THE CASE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1