BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE VASCULAR LINEAR STAPLER - 30 MM

    MDR report key: 3143439 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02765
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY CONTACT. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT. IN ADDITION FIVE CARTRIDGES WERE RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLES WERE NOTED TO HAVE A PROPER B-FORMATION AND THE STAPLE LINE WAS COMPLETE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. 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 LIVER TRANSPLANT PROCEDURE THE STAPLER HAD BEEN FIRED 4 TIMES WITHOUT INCIDENT. ON THE LAST FIRING IT WAS NOTED THAT THE STAPLE LINE WAS NOT COMPLETE AND THERE APPEARED TO BE STAPLES "MISSING". ANASTOMOSIS WAS COMPLETED BY SUTURE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245380 PROXIMATE** RELOADABLE VASCULAR LINEAR STAPLER - 30 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CE3R

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD XR30V