BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 3120087 · Received April 30, 2013

    Report

    Report Number
    3120087
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ETHICON ENDOSURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE TETHERING SUTURE TO SUTURE TIE ON TROCAR, SUTURE TIE BUSTED OFF TROCAR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC COLON RESECTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188831 ENDOPATH XCEL BLUNT TIP TROCAR TROCAR GCJ ETHICON ENDOSURGERY, INC. * K4C18E

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR