BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG

    MDR report key: 1871344 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05887
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 7, 2010
    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). FIRING TRIGGER TEETH THE ANALYSIS SHOWED THAT THE (B)(4) DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A (B)(4) FULLY FIRED RELOAD PRESENT. IN ADDITION, THE DEVICE WAS RETURNED WITH THE KNIFE EXPOSED. 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. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE IN PREVIOUS FIRINGS. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DOCTOR FELT A DIFFICULTY IN FIRING. THE DIFFICULTY WAS CONTINUED FROM THE FIRST TO THE THIRD FIRING. THE DOCTOR COMMENTED THAT WHEN THE FIRING TRIGGER HAD BEEN GRASPED, A RASPING SOUND HAD BEEN HEARD. THE CARTRIDGES WERE LOADED INTO THE DEVICE WITHOUT ANY PROBLEMS AND THE DEPLOYED STAPLES WERE FORMED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD PRODUCT #- (B)(4)