BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PATH

    MDR report key: 147232 · Received January 5, 1998

    Report

    Report Number
    147232
    Event Type
    Malfunction
    Date Received
    January 5, 1998
    Date of Event
    October 2, 1997
    Report Date
    November 12, 1997
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING LAP CHOLE-THE SEALS FROM 3-11MM TROCARS WERE MALFUNCTIONING & CAUSED LEAKAGE OF GAS MAKING IT DIFFICULT TO DO CASE-THE SEALS APPEARED TO BE SHREDDED WHEN THE RT. ANGLE DISSECTOR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PATH DISPOSABLE TROCAR GCT ETHICON ENDO SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR