BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI 6 SFC / S3

    MDR report key: 653533 · Received December 16, 2005

    Report

    Report Number
    2431026-2005-00008
    Event Type
    Injury
    Date Received
    December 16, 2005
    Date of Event
    November 8, 2005
    Report Date
    December 16, 2005
    Manufacturer
    CARL ZEISS SURGICAL GMBH
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTS THAT THE MICROSCOPE WAS DRAPED AND ACCESSORIES ATTACHED TO PERFORM OCULAR PROCEDURE. THE MICROSCOPE PARTIALLY DETACHED FROM THE STAND AND CONTACTED THE PT'S FACE AROUND THE EYE, LEAVING NO VISIBLE INJURY. THE MICROSCOPE DID NOT COMPLETELY FALL AS IT REMAINED CONNECTED WITH FIBER OPTIC AND ELECTRICAL CABLE. THE MICROSCOPE WAS REATTACHED AND THE PROCEDURE WAS COMPLETED. THE FACILITY INDICATED THAT BECAUSE OF THE NATURE OF CONTACT INJURY, IT COULD NOT RULE OUT THAT INJURY WOULD DEVELOP OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI 6 SFC / S3 SURGICAL MICROSCOPE EPT CARL ZEISS SURGICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other