BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 3030141 · Received April 2, 2013

    Report

    Report Number
    3005075853-2013-01536
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 2013
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    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. IN ADDITION 4 RELOADS WERE RECEIVED FULLY FIRED, LOCKED. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE WHEN FIRING THE DEVICE FOR THE THIRD TIME, THE STAPLE LINE CAME OUT SHORT. AT LEAST 15MM. THE DEVICE DID FULLY CUT THE TISSUE BUT ONLY PARTIALLY STAPLE THE TISSUE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134040 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C15X

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD TCR55