BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3080652 · Received April 26, 2013

    Report

    Report Number
    3005075853-2013-01991
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? COLON. AT WHAT LOCATION ON THE TISSUE? DO NOT KNOW. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND. ECHELON STRAIGHT/FLEX: DURING WHICH STROKE DID THE EVENT OCCUR? 2ND. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? DO NOT KNOW. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? DO NOT KNOW. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. THE ANALYSIS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A BLUE CARTRIDGE PARTIALLY FIRED 1/16 WAS LOADED IN THE DEVICE. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE CLOSED AND OPENED AS INTENDED DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC COLECTOMY PROCEDURE, THE DEVICE WOULD NOT FIRE WHEN THE FIRING TRIGGER WAS PULLED. THE DEVICE WAS REMOVED USING THE RELEASE BUTTONS. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182544 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C705

    Patients

    Seq Age Sex Outcome Treatment
    1