BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL

    MDR report key: 3032167 · Received March 13, 2013

    Report

    Report Number
    3032167
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A LAPAROSCOPIC PROCEDURE AND WAS REMOVING THIS 5MM TROCAR WHEN IT BROKE IN HALF AND THE END PIECE STAYED IN THE PATIENT. IT WAS EASILY REMOVED SO NO PATIENT HARM TO PLACE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106154 ENDOPATH XCEL LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO SURGERY XCEL #5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR NO OTHER THERAPIES