BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 1962255 · Received January 18, 2011

    Report

    Report Number
    3005075853-2011-00229
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANVIL FORMER. THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT WAS NOTED THAT THE STAPLES WERE PARTIALLY FORMING AND EJECTING FROM THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE ANVIL WAS NOTED TO BE DEFORMED. THIS DEFORMATION IN THE ANVIL WILL PREVENT THE STAPLE TO BE HELD IN THE FIRING CHAMBER FOR ITS COMPLETE FORMATION, RESULTING IN AN EJECTED STAPLE. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A UNKNOWN PROCEDURE. ON THE INITIAL FIRING, THE DEVICE FAILED. THE DEVICE STAPLED BUT WOULD NOT CLAMP ON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** SKIN STAPLER 35 WIDE SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA G4TH9L

    Patients

    Seq Age Sex Outcome Treatment
    1