BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RH ROTATING HEAD SKIN STAPLER

    MDR report key: 2240961 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03716
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. DAMAGED ANVIL FORMER THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT WAS NOTED THAT THE STAPLES WERE PARTIALLY FORMING AND EJECTED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WERE NOT HOLDING TO THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM. NO FURTHER DETAIL IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RH ROTATING HEAD SKIN STAPLER SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA H43X5H

    Patients

    Seq Age Sex Outcome Treatment
    1