BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 2222116 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03487
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN CYSTECTOMY, THE DEVICE CUT BUT DID NOT STAPLE. THIS HAPPENED DURING THE INITIAL FIRING WITH A BLUE LOAD. THEY USED ANOTHER DEVICE AND FIRED ACROSS THE CUT LINE AND COMPLETED THE PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43G01

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE