BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD - STANDARD

    MDR report key: 3031555 · Received April 2, 2013

    Report

    Report Number
    3005075853-2013-01556
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SWING TAB IN UNLOCKED POSITION. THE ANALYSIS RESULTS FOUND THAT THE CARTRIDGE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH NO INSTRUMENT. THE RELOAD WAS RECEIVED WITH THE 2 MOST PROXIMAL DRIVERS UP, AND THE SWING TAB IN THE UNLOCKED POSITION. IT SHOULD BE NOTED THAT AFTER THE STAPLE RETAINER HAS BEEN REMOVED, AN INADVERTENT MOVEMENT OF THE FIRING KNOB COULD CAUSE THE WEDGES TO MOVE FORWARD AND THEREFORE CAUSE THE STAPLES TO BECOME DISLODGED. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE CARTRIDGE WAS TESTED FOR FUNCTIONALITY WITH A TEST INSTRUMENT AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE INSTRUMENT FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES 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 LAPAROSCOPY ASSISTED DISTAL GASTRECTOMY PROCEDURE THERE WAS AN INCOMPLETE STAPLE LINE. THE DEVICE WAS RELOADED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134639 PROXIMATE** LINEAR CUTTER RELOAD - STANDARD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AT33

    Patients

    Seq Age Sex Outcome Treatment
    1