BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON XCEL 5MM TROCAR

    MDR report key: 1780731 · Received July 16, 2010

    Report

    Report Number
    1780731
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 16, 2010
    Manufacturer
    STERILMED INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE THE TROCAR LEAKED. TWO OTHER INCIDENTS OF LEAKING STERIL MED 5MM REPROCESSED TROCARS WERE REPORTED HOWEVER DEVICE IDENTIFIERS WERE NOT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON XCEL 5MM TROCAR TROCAR SLEEVE 5MM GCJ STERILMED INC 5MM X 100MM JOB #: 856558

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR