BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2112404 · Received June 3, 2011

    Report

    Report Number
    3005075853-2011-02275
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANCILLARY TROCAR AND UNCUT WASHER - UNBLEMISHED THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH THE ANCILLARY TROCAR TIP BROKEN. THE DEVICE WAS RECEIVED WITH THE BREAKAWAY WASHER PRESENT, UNCUT AND THE DEVICE WAS VOID OF STAPLES. THIS IS CONSISTENT WITH ACTUATING THE FIRING TRIGGER WITHOUT THE ANVIL ATTACHED TO THE DEVICE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; THE DEVICE 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A GASTRIC BYPASS PROCEDURE, SURGERY HAD NOT STARTED YET. THE DEVICE NEVER TOUCHED THE PATIENT. THE SCRUB TECH NOTICED THAT WHEN THE DEVICE WAS PLACED ON THE TABLE, THE TIP OF THE BLUE TROCAR WAS HALF BROKEN. THE SURGEON NEEDS TO THREAD A SUTURE THROUGH THAT HOLE TO COMPLETE HIS TRANS-ABDOMINAL GASTRO-JEJUNOSTOMY, BECAUSE THE TIP WAS PARTLY BROKEN, THE SUTURE COULD NOT BE THREADED. THEY OPENED A NEW DEVICE AND USED THE NEW DEVICE ON THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

    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