BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RH ROTATING HEAD SKIN STAPLER

    MDR report key: 2112263 · Received June 3, 2011

    Report

    Report Number
    3005075853-2011-02271
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    January 7, 2011
    Report Date
    May 13, 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
    TN, 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 PRECOCK MECHANISM. DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION. AFTER FURTHER INSPECTION, IT WAS NOTED THAT THE PRE-COCK MECHANISM WAS DAMAGED. EVEN THOUGH THE PRE-COCK MECHANISM WAS NOT FUNCTIONAL, THE DEVICE WAS TESTED FOR FUNCTIONALITY BY MANUALLY RETURNING THE FIRING TRIGGER TO ITS ORIGINAL POSITION. THE DEVICE FIRED THE REMAINING STAPLES AS INTENDED AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH DRY BODY FLUIDS. AFTER FURTHER INSPECTION, IT WAS NOTED THAT THE PRE-COCK MECHANISM WAS DAMAGED. EVEN THOUGH THE PRE-COCK MECHANISM WAS NOT FUNCTIONAL, THE BODY FLUIDS WERE CLEANED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY BY MANUALLY RETURNING THE FIRING TRIGGER TO ITS ORIGINAL POSITION. THE DEVICE FIRED THE REMAINING STAPLES AS INTENDED AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. THE DEVICES WERE DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE PRE-COCK RIBS WERE FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE PRE-COCK MECHANISM TO BECOME DAMAGED, IT IS POSSIBLE THAT THE FIRING SEQUENCE WAS INTERRUPTED AND THE TRIGGER WAS FORCED BACK TO THE OPEN POSITION CAUSING THE DAMAGE TO THE PRE-COCK SPRING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE, THERE WERE TWO DEVICES USED IN THE PROCEDURE. WITH THE FIRST DEVICE, THE STAPLES WOULD NOT HOLD WHEN ATTACHED TO THE DRAPE; IT WAS NOT USED ON THE PATIENT. THE SECOND DEVICE JAMMED AND WOULD NOT FIRE. IT IS NOT KNOWN HOW THEY COMPLETED THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE 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 G4UAG4

    Patients

    Seq Age Sex Outcome Treatment
    1