BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 3832955 · Received May 27, 2014

    Report

    Report Number
    3005075853-2014-03554
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 7, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON THE 2ND FIRING, PLEASE EXPLAIN WHAT IS MEANT BY, THE DEVICE DID NOT FUNCTION PROPERLY? --- THE DEVICE WAS LOCKED OUT AT THE 2ND FIRING. 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 16 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. IN ADDITION TWO CARTRIDGE RELOADS WERE RECEIVED, THE RELOAD B WAS RECEIVED WITH 35 DRIVERS UP AND SWING TAP IN THE LOCKED POSITION, THE RELOAD C WAS RECEIVED FULLY FIRED. 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. FOR ADDITIONAL INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE CARTRIDGE RELOADS (A , B) WERE MANUALLY UNLOCKED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE RELOADS (A, B) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN IEUS PROCEDURE, THE DOCTOR FELT THAT THE DEVICE DID NOT FUNCTION PROPERLY AT THE 2ND FIRING. AT THE 3RD FIRING, STAPLES OF THE DISTAL END WERE NOT FORMED PROPERLY. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311185 PROXIMATE LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOADS - TCR75