BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICING LNR CUTR/6 ROW BL

    MDR report key: 1162303 · Received September 8, 2008

    Report

    Report Number
    3005075853-2008-01561
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 31, 2008
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED IN THE DEVICE. HOWEVER, TWO CARTRIDGES WERE RECEIVED INSIDE THE BAG, CARTRIDGE (B) WAS RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT NORMAL, CARTRIDGE (C) WAS RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT DAMAGED. THE DAMAGE TO THE SPRING CARTRIDGE LOCKOUT IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. IN ADDITION, THE INSTRUCTIONS FOR USE STATE, "THE FIRING STROKE MUST BE COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. NOTE: 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." THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS. CARTRIDGE B: D5KF62, 6R45B, PARTIALLY FIRED 1/10, NOT RECYCLED, LOCKOUT NORMAL. CARTRIDGE C: D5KC1U, TR45W, PARTIALLY FIRED 1/10, NOT RECYCLED, LOCKOUT DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, THE HANDLES LOCKED AND THE RELOADS DID NOT FIRE. IT IS UNK HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICING LNR CUTR/6 ROW BL GDW ETHICON ENDO-SURGERY, LLC. NA D4J64P

    Patients

    Seq Age Sex Outcome Treatment
    1