BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD - STANDARD

    MDR report key: 3122315 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02457
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 28, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SWING TAB IN UNLOCKED POSITION. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES ¿ DISTAL, PROXIMAL OR IN THE MIDDLE OF THE STAPLE LINE? THE MALFORMED STAPLES WERE IN THE DISTAL PART OF THE STAPLE LINE. WHERE THE MALFORMED STAPLES ON THE LINE CLOSEST TO THE CUT LINE OR IN ALL OF THE ROWS? THE MALFORMED STAPLES WERE IN ALL OF THE ROWS. WHERE THE STAPLE LEGS UNFORMED OR DID THEY HAVE IRREGULAR SHAPES? SOME STAPLE LEGS UNFORMED AND SOME HAD IRREGULAR SHAPES. ON WHICH FIRING DID THE EVENT OCCUR? ON 1ST FIRING. HOW WAS THE FAILURE DETECTED (LEAK TEST OR VISUALLY)? THE FAILURE WAS VISUALLY. WAS THE DEVICE FIRED OVER AN EXISTING STAPLE LINE OR CLIP? NO. THE ANALYSIS RESULTS FOUND THAT THE CARTRIDGE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH NO INSTRUMENT. THE SWING TAB WAS FOUND TO BE IN THE UNLOCKED POSITION. IT APPEARS THAT THE FIRING KNOB WAS NOT RETURNED TO THE ORIGINAL "RETURN KNOB HERE" POSITION BEFORE RELOADING THE DEVICE, CAUSING THE FIRST DRIVER TO GO UP AND THE STAPLES TO FALL OUT. IT SHOULD ALSO 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIVER TRANSPLANT PROCEDURE SOME STAPLES WERE MALFORMED AFTER FIRING. THE SURGEON CHANGED TO HAND SEWING TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223908 PROXIMATE** LINEAR CUTTER RELOAD - STANDARD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AJ5D

    Patients

    Seq Age Sex Outcome Treatment
    1