BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 3113424 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02329
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 20, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? THE DEVICE WAS USED IN A TOTAL GASTRECTOMY ON WHICH FIRING DID THE EVENT OCCUR? 1ST. AREA OF STAPLE LINE FAILURE? WHOLE STAPLE LINE. WHAT WAS THE APPEARANCE OF THE STAPLES (IRREGULAR SHAPES OR LEGS OPEN)? LEGS OPEN. WAS THE TISSUE EXCISED PRIOR TO EXAMINING THE STAPLE LINE? I CAN'T UNDERSTAND THIS QUESTION, FOR THE TL60 IS A STAPLER AND NOT CUT THE TISSUE. WAS A LEAK TEST PERFORMED OR WAS THE STAPLE LINE INSUFFICIENCY VISUALLY DETECTED? THE STAPLE LINE WAS INSUFFIENCY VISUALLY DETECTED. WAS THE DEVICE FIRED OVER AN EXISTING STAPLE LINE OR CLIP? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WERE MALFORMED AFTER THE FIRING. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214835 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C686

    Patients

    Seq Age Sex Outcome Treatment
    1