BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 2060797 · Received April 18, 2011

    Report

    Report Number
    3005075853-2011-01535
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 23, 2011
    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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE ANALYSIS RESULTS FOUND THAT THE ATW35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RETURNED FULLY LOADED WITH STAPLES AND WAS NOT LOADED CORRECTLY/COMPLETELY ON THE DEVICE. THE CARTRIDGE WAS TAKEN OFF OF THE DEVICE AND PLACED BACK ON AND IT CLICK INTO PLACE AS INTENDED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES. 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 INTO THE DEVICE AS INTENDED AND DID NOT FELL OUT DURING THE VISUAL AND FUNCTIONAL TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS/ LOBECTOMY PROCEDURE, THE CARTRIDGE FELL OUT OF THE DEVICE AND INTO THE PATIENT. THE PROBLEM OCCURRED PRIOR TO PLACING THE DEVICE ON THE VESSEL. THE DEVICE WAS RELOADED BUT THE CARTRIDGE FELL OUT AGAIN. THE CARTRIDGES WERE ABLE TO BE RETRIEVED THROUGH THE EXISTING INCISION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4U85E

    Patients

    Seq Age Sex Outcome Treatment
    1