BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVIEW

    MDR report key: 1729500 · Received June 15, 2010

    Report

    Report Number
    MW5016401
    Event Type
    Injury
    Date Received
    June 15, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CQ LABS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TROCAR LEAKED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIVIEW TROCAR GCJ CQ LABS 11MM CB11LT G9JN5H

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Disability