BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPMI MOVENA ON S7 FLOOR STAND

    MDR report key: 2163684 · Received June 16, 2011

    Report

    Report Number
    9615010-2011-00009
    Event Type
    Other
    Date Received
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CARL ZEISS SURGICAL GMBH
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A MANUFACTURER SERVICE REPRESENTATIVE PERFORMED AN ON-SITE PREVENTIVE MAINTENANCE OF BOTH MICROSCOPE S/N (B)(4) AT THE HOSPITAL. THIS INCLUDED SAFETY FUNCTION TESTS, CONFIRMATION UV FILTER WAS IN PLACE AND THAT THE LIGHT INTENSITY FILTER WAS FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    HOSPITAL REPORTED A PT RECEIVED A TISSUE INJURY/BURN (SMALL BLISTER) POSTERIOR SIDE RIGHT EAR DURING TYMPANOPLASTY PROCEDURE PERFORMED WITH SURGICAL MICROSCOPE ON DATE UNKNOWN. ON POST-OP VISIT, DATE UNKNOWN, THE AREA APPEARED SMALL AND FILLED WITH CLEAR FLUID. MEDICAL INTERVENTION REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI MOVENA ON S7 FLOOR STAND EPT CARL ZEISS SURGICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other