BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*STEALTH CIR STAPLER

    MDR report key: 1841439 · Received September 22, 2010

    Report

    Report Number
    3005075853-2010-05469
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 3, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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 BEEN 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. 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 PRIOR TO A GASTRIC ROUX-EN-Y PROCEDURE, WHEN THE DEVICE PACKAGE WAS OPENED, THEY NOTICED THE BLUE ANCILLARY TROCAR WAS CHIPPED ON THE DISTAL END. IT WAS NOT USED. A NEW ONE WAS USED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH*STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA G4TH3X

    Patients

    Seq Age Sex Outcome Treatment
    1