BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI PENTERO

    MDR report key: 3031267 · Received April 4, 2006

    Report

    Report Number
    3031267
    Event Type
    Injury
    Date Received
    April 4, 2006
    Date of Event
    January 17, 2006
    Report Date
    March 20, 2006
    Manufacturer
    CARL ZEISS SURGICAL INC.
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT MAY HAVE RECEIVED A BURN DURING SURGERY FROM THE MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI PENTERO O.R. MICROSCOPE EPT CARL ZEISS SURGICAL INC. OPMI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention