BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3112321 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02318
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    March 26, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. DAMAGED SPRING CARTRIDGE LOCKOUT TAB, INCOMPLETE-INTERRUPTED CYCLE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH CARTRIDGE LOCKOUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IN MATERIALS; THERE WAS A NOTE, STAPLER WOULD NOT FIRE. NO ADDITIONAL INFORMATION WAS PROVIDED. THEY DO NOT KNOW HOW LONG THE DEVICE HAS BEEN THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213458 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1