BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2162972 · Received July 15, 2011

    Report

    Report Number
    3005075853-2011-02894
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 23, 2011
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT (A) WAS RETURNED NON-FUNCTIONAL DUE TO A NON-CONFORMING STAPLE STACK. IN ADDITION, ONE STAPLE WAS FOUND JAMMED IN THE CARTRIDGE NOSE. WHEN THE STAPLE STACK IS FOUND TO BE NONCONFORMING, STAPLES WILL BECOME JAMMED IN THE CARTRIDGE, NOT ALLOWING THE STAPLES TO PROPERLY ADVANCE AND POSSIBLY PREVENTING THE DEVICE FROM FIRING. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE STAPLE WALL WAS NOTED TO BE DAMAGED, NOT ALLOWING THE STAPLES TO FEED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLE WALL BECAME DAMAGED, 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. INSTRUMENT (B) 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A C-SECTION PROCEDURE, WITH BOTH DEVICES THE STAPLES WERE NOT FORMING. 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** SKIN STAPLER 35 WIDE SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA H43L89

    Patients

    Seq Age Sex Outcome Treatment
    1