BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 2980777 · Received February 27, 2013

    Report

    Report Number
    3005075853-2013-00872
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE/INTERRUPTED CYCLE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD HAD THE PROXIMAL 32 DRIVERS UP WITHOUT STAPLES, AND THE REMAINING DRIVERS DOWN WITH STAPLES PRESENT. THE RETURNED CARTRIDGE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. IT SHOULD BE NOTED THAT THE CARTRIDGE RELOAD IS DESIGNED TO LOCKOUT, AS A SAFETY FEATURE, IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE RELOAD. IN ADDITION FAILURE TO COMPLETE THE STROKE MAY RESULT IN INCOMPLETE STAPLE LINE. THE CARTRIDGE RELOAD WAS MANUALLY UNLOCKED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE RELOAD AND IT FIRED, CUT, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE DEVICE FIRED WITH NO DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ILEOSTOMY CLOSURE PROCEDURE, THE SURGEON PUSHED THE FIRING KNOB AND THE KNOB BENT WHICH RESULTED IN MALFORMED STAPLES. THEN A SECOND LOAD WAS LOAD AND FIRED AND THERE WERE MALFORMED STAPLES AGAIN. THIS WAS THE FIRST AND SECOND FIRINGS ON BOWEL. HAND SUTURING WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84200 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CT4H

    Patients

    Seq Age Sex Outcome Treatment
    1