BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2170439 · Received July 21, 2011

    Report

    Report Number
    3005075853-2011-02911
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 27, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (DEVICE A): CARTRIDGE FLASH. (DEVICES B, C AND D): DAMAGED ANVIL FORMER. (DEVICE E): DAMAGED STAPLE WALL. (DEVICE F): (B)(4). DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED AND FORMED 4 STAPLES AS INTENDED. AFTER THE FOURTH FIRING, THE STAPLES BECAME MISALIGNED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND FLASH WAS FOUND IN THE CARTRIDGE. THIS WAS CAUSING THE STAPLES TO BECOME MISALIGNED. NO CONCLUSION COULD BE REACHED AS TO HOW THE CARTRIDGE BECAME DAMAGED. DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED AND FORMED 4 STAPLES AS INTENDED. HOWEVER, AFTER THE FOURTH FIRING, THE DEVICE STARTED EJECTING THE STAPLES. DEVICE (C) WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED AND FORMED 1 STAPLE AS INTENDED. HOWEVER, AFTER THIS THE DEVICE STARTED EJECTING THE STAPLES. DEVICE (D) WAS RECEIVED WITH A NON-CONFORMING STAPLE STACK. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT WAS NOTED THAT THE STAPLES WERE PARTIALLY FORMING AND EJECTED FROM THE DEVICE. DEVICES (B), (C) AND (D) WERE 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. DEVICE (E) WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY THE DEVICE FIRED AND FORMED THE REMAINING STAPLES AS INTENDED. HOWEVER, THE DEVICE WAS NOTED TO BE DAMAGED AS THE STAPLES WOULD NOT ADVANCE AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER BOX SHAPE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE STAPLE WALL WAS FOUND DAMAGED. DEVICE (F) WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY THE DEVICE FIRED AND FORMED THE REMAINING 16 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER BOX SHAPE. 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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE GIVEN TO THE REPORTER WITH LIMITED INFORMATION. THE DEVICES EITHER JAMMED AFTER ONLY SEVERAL FIRINGS OR DEPLOYED MALFORMED STAPLES. NO OTHER INFORMATION IS AVAILABLE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1