BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHOLECYSTECTOMY KIT W/TROCAR

    MDR report key: 77719 · Received March 21, 1997

    Report

    Report Number
    MW1010999
    Event Type
    Other
    Date Received
    March 21, 1997
    Report Date
    February 25, 1997
    Manufacturer
    RICHARD ALLAN MEDICAL INDUSTRIES, INC.
    Product Code
    GCJ
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TROCAR HAS A RUBBER RING IN THE CANNULA PORTION TO PREVENT CO2 FROM ESCAPING. THE TROCAR DOES NOT PREVENT THIS. ALSO WHEN THE SURGEON INSERTS ANY LAPOROSCOPIC INSTRUMENT AND RETRACTS IT, THE REDUCER CAP PULLS OFF, DELAYING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLECYSTECTOMY KIT W/TROCAR CHOLECYSTECTOMY KIT W/TROCAR GCJ RICHARD ALLAN MEDICAL INDUSTRIES, INC. * K-11NOV01

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other