BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDOSURGERY, INC

    MDR report key: 137770 · Received December 11, 1997

    Report

    Report Number
    137770
    Event Type
    Malfunction
    Date Received
    December 11, 1997
    Date of Event
    November 8, 1997
    Report Date
    November 12, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF DISPOSABLE TROCAR RESULTING IN RING PORTION SEPARATING FROM INSTRUMENT AND ENTERING ABDOMINAL CAVITY. THE RING WAS RETRIEVED. INTRAOPERATIVE PHOTOS VERIFIED. NO PT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSURGERY, INC ETHICON TRISTAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. 511 S 11 MM K47X5W 2002-08

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other