BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RH ROTATING HEAD SKIN STAPLER

    MDR report key: 1946387 · Received January 4, 2011

    Report

    Report Number
    3005075853-2011-00035
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 15, 2010
    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
    WI, 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 CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED AND FORMED 10 STAPLES AS INTENDED. HOWEVER, AFTER THE 10TH FIRING, THE DEVICE STARTED EJECTING THE STAPLES. 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. IT SHOULD BE NOTED THAT 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. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY PROCEDURE, THE DEVICE WOULD NOT STAPLE. THE STAPLES WOULD COME OUT, HOWEVER, NOT STAPLE INTO THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1