BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 2240896 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03713
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ANCILLARY TROCAR. THE ANALYSIS RESULTS FOUND THAT THE ANVIL OF AN ECS29 WAS RECEIVED WITHOUT A DEVICE. THE ANVIL WAS RECEIVED WITH THE WASHER UNCUT; IN ADDITION, THE TIP OF THE ANCILLARY TROCAR WAS BROKEN AND INSIDE THE ANVIL SPLINE. NO FUNCTIONAL TEST COULD BE PERFORMED. IT COULD NOT BE ASCERTAINED AS TO HOW THE DAMAGE TO THE ANCILLARY TROCAR OCCURRED. IT SHOULD BE NOTED THAT IF TORQUE OR EXCESS FORCE IS APPLIED TO THE ANCILLARY TROCAR, IT MAY CAUSE THE TROCAR TO BREAK. IT SHOULD BE NOTED THAT TO DETACH THE ANCILLARY TROCAR, IT SHOULD BE ROTATED 45 DEGREES IN THE ANVIL SHAFT SO THAT THE FINGER NOTCHES ARE PERPENDICULAR TO THE LOCKING SPRINGS (UNLOCKED POSITION). UTILIZING THE FINGER NOTCHES, PULL THE ANCILLARY TROCAR OUT OF THE ANVIL SHAFT. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN COLOSTOMY TAKE DOWN PROCEDURE, THE ANCILLARY TROCAR BROKE AFTER THEY HAD PLACED THE ANVIL. THE PIECE THAT BROKE OFF STAYED IN THE ANVIL AND DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS PULLED AND THE BOWEL WAS RE-OPENED AND THE ANVIL WAS REMOVED FROM THE PATIENT WITH THE BLUE ANCILLARY PIECE STILL IN THE ANVIL. ANOTHER ANVIL WAS PLACED AND THE CASE WAS COMPLETED WITH NO CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM CIRCULAR STAPLERS GDW ETHICON ENDO-SURGERY, LLC. NA H4363H

    Patients

    Seq Age Sex Outcome Treatment
    1