BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2142515 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02649
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 8, 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
    AU
    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 SHOWED THAT FOUR ANVILS WERE RECEIVED. ANVIL (A), (C) AND (D) WERE RECEIVED WITH THE ANCILLARY TROCAR INSERTED IN THE ANVIL. THE ANCILLARY TROCARS WERE NOTED TO HAVE THE TIPS BROKEN AND SCRATCHED. ADDITIONALLY THE ANVIL BREAKAWAY WASHERS WERE CUT ON THE ANVILS; ANVIL (B) WAS RECEIVED WITH THE ANCILLARY TROCAR INSERTED IN THE ANVIL. THE TROCAR WAS NOTED TO BE BROKEN AND WITH SCRATCHES. THE ANVIL BREAKAWAY WASHER WAS UNCUT. IT COULD NOT BE ASCERTAINED AS TO HOW THE DAMAGE TO THE ANCILLARY TROCARS 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. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, IT WAS VERY HARD TO MOVE THE BLUE PIN FROM THE STAPLER. THE SAME PROBLEM HAPPENED WITH FOUR DEVICES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1