BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELOADABLE LINEAR CUTTER

    MDR report key: 2142536 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02653
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 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
    NY, 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 NO RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITH OUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE DEVICE STAPLED AND CUT THEN SKIPPED IN THE MIDDLE THEN STAPLED AND CUT. THE DEVICE FELT LIKE IT WAS SKIPPING THE CHANNELS. SCISSORS WERE USED TO CUT OUT THAT AREA OF TISSUE AND TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELOADABLE LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H4359A

    Patients

    Seq Age Sex Outcome Treatment
    1