BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 1964310 · Received January 19, 2011

    Report

    Report Number
    3005075853-2011-00256
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED: THE LAPAROSCOPIC GASTRIC BYPASS WAS CONVERTED TO OPEN, WITH SMALL INCISION, REMOVED ANVIL THEN DID A HAND ANASTOMOSIS. THE CASE WAS PROLONGED BY 1½ HOURS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THE SPIKE OF THE TROCAR WAS IN THE ANVIL. THE SURGEON CREATED THE POUCH THEN WAS TRYING TO REMOVE THE BLUE TROCAR PER AS USUAL. THE TROCAR BROKE IN THE POST OF THE ANVIL. THERE WERE TWO TYPES OF GRASPERS HOLDING THE POST ONE WAS A BABCOCK AND THE OTHER WAS A WAVY GRASPER WITH SERRATED. THE DEVICE WAS NOT FIRED AT ALL ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANCILLARY TROCAR. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH THE ANCILLARY TROCAR TIP DAMAGED. THE DEVICE WAS RECEIVED WITH THE BREAKAWAY WASHER PRESENT, UNCUT AND THE DEVICE WAS FULLY LOADED WITH STAPLES, INDICATING THAT THE DEVICE HAD NOT BEING FIRED. A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. 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. 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 THE DEVICE WAS USED DURING A GASTRIC BYPASS. IT WAS REPORTED THAT THE ANVIL WAS IN PLACE AND THE TROCAR TIP BROKE OFF DURING THE PROCEDURE. THE CONSEQUENCE TO THE PATIENT IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S