BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1834612 · Received December 6, 2007

    Report

    Report Number
    1527736-2007-08353
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 12, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    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). EVAL SUMMARY - THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED AND WITH THE SPRING CARTRIDGE LOCK OUT DAMAGED. THE DAMAGE TO THE SPRING CARTRIDGE LOCKOUT IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. IN ADDITION TWO CARTRIDGES WERE RECEIVED INSIDE THE BAG, CARTRIDGE B WAS RECEIVED VOID OF STAPLES AND WITH NO DAMAGE TO THE LOCKOUT, CARTRIDGE C WAS RECEIVED FULLY LOADED WITH STAPLES AND WAS TESTED FOR FUNCTIONALITY WITH A TEST DEVICE. THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, AFTER CHANGING THE CARTRIDGE, THE FIRING WAS UNUSUAL. IT FELT MORE STIFF THAN USUAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR/6 ROW BL GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1