BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED ETHICON 5MM TROCAR

    MDR report key: 1933066 · Received December 14, 2010

    Report

    Report Number
    1933066
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6), FEMALE, ADMITTED TO THE MEDICAL CENTER ON (B)(6), 2010 FOR LAPAROSCOPIC CHOLECYSTECTOMY. THE SURGEON REPORTED THAT THE 5MM PORT USED WAS LEAKING GAS FROM THE ABDOMEN. THERE WAS NO INJURY AND NO EFFECT ON PATIENT CARE. THE TROCAR WAS LEAKING CO2 BUT IT WAS LEAKING SLOWLY AND STAFF WAS ABLE TO KEEP UP WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPROCESSED ETHICON 5MM TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. 5MM TROCAR PORT NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other