BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRISTAR

    MDR report key: 147255 · Received February 2, 1998

    Report

    Report Number
    147255
    Event Type
    Injury
    Date Received
    February 2, 1998
    Date of Event
    December 27, 1997
    Report Date
    January 5, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC./A JOHNSON & JOHNSON G.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY A 10-12MM TROCAR CAME APART AND THE 'O' RING FELL INTO THE PT'S ABDOMINAL WALL - PHYSICIAN REMOVED 'O' RING WITH NO F/U REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRISTAR TROCAR GCJ ETHICON ENDO-SURGERY, INC./A JOHNSON & JOHNSON G. 512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention