BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISU 200 ON S8 STAND

    MDR report key: 1355330 · Received April 2, 2009

    Report

    Report Number
    2431026-2009-00002
    Event Type
    Injury
    Date Received
    April 2, 2009
    Report Date
    April 1, 2009
    Manufacturer
    CARL ZEISS SURGICAL, GMBH
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISU 200 USES A RETINAL PROTECTION FILTER, GG 475, TO REDUCE THE EYE'S EXPOSURE TO LIGHT RADIATION DURING LONG SURGICAL PROCEDURES. THE SYSTEM FEATURES A CUSTOM CONFIGURATION OF THE FILTER POSITIONS. THE FILTER KNOB HAS 4 POSITIONS: NO FILTER, GG 475 FILTER, KK 40 FILTER, NO FILTER. DURING AN INVESTIGATION, THE MANUFACTURER DISCOVERED THAT THE USER MANUAL DELIVERED WITH VISU 200 INSTRUMENTS ON S 8 SUSPENSION SYSTEMS FROM EARLY 1999 TO 2000 HAD INCORRECT FILTER POSITIONING INSTRUCTIONS. THE USER MANUAL INSTRUCTS THE USE OF GG 475 FILTER FOR CATARACT SURGERY AND STATED THAT THE FILTER WAS IN POSITION 2, WHEN IN FACT, THE GG 475 FILTER IS LOCATED AT POSITION 1. BY CHOOSING POSITION 2, THE USER WOULD SELECT THE KK 40 FILTER WHICH ALSO REDUCES THE LIGHT INTENSITY AND ALLOWS LONGER SURGERY TIMES, BUT NOT TO THE SAME DEGREE AS THE GG 475 FILTER. THE USAGE OF THE GG 475 FILTER IS EASILY DETECTABLE BY THE USER, BECAUSE ILLUMINATION OF THE LIGHT FIELD BECOMES YELLOWISH. THE MANUFACTURER FOUND OUT THAT VISU 200 INSTRUMENTS DELIVERED AFTER THAT MONTH, HAVE THE CORRECT FILTER POSITION INSTRUCTION. IN THEIR REPORT, THE HOSPITAL COULD NOT CATEGORICALLY ESTABLISH A LINK BETWEEN THE INCORRECT INSTRUCTIONS PROVIDED IN THE USER MANUAL AND THE RETINAL DAMAGE TO THE PATIENTS. NONETHELESS, A SAFETY ALERT IS BEING CARRIED OUT BY THE MANUFACTURER. SO FAR NO OTHER COMPLAINTS OR INCIDENTS OF THIS NATURE HAVE BEEN REPORTED BY USER FACILITIES OR HEALTH-CARE PROFESSIONALS.

    Description of Event or Problem · 1

    IN EARLY 2009, THE HOSPITAL REPORTED THAT, OVER A PERIOD OF SEVERAL MONTHS, 4 PATIENTS RECEIVED PHOTOCHEMICAL DAMAGE TO THE RETINA DURING EYE SURGERY. THE HOSPITAL REPORTED THESE INCIDENTS TO THE DEVICE TECHNOLOGY & SAFETY - IMAGING & ACUTE CARE DIVISION OF THE MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY IN OTHER COUNTRY. IN THE REPORT FROM THE HOSPITAL, IT WAS NOTED THAT THE USER MANUAL RECOMMENDS THE USE OF THE GG 475 FILTER FOR CATARACT SURGERY AND STATES THAT THIS FILTER IS IN POSITION 2, WHEN IN FACT, THE GG 475 FILTER IS LOCATED AT POSITION 1. BY CHOOSING POSITION 2, THE DOCTOR WOULD HAVE SELECTED THE KK 40 FILTER WHICH ALSO REDUCES THE LIGHT INTENSITY AND ALLOWS LONGER SURGERY TIMES, BUT NOT TO THE SAME DEGREE AS THE GG 475 FILTER. THE USAGE OF THE GG 475 FILTER IS EASILY DETECTABLE BY THE USER, BECAUSE ILLUMINATION OF THE LIGHT FIELD BECOMES YELLOWISH. A COMPANY REPRESENTATIVE INSPECTED THE MICROSCOPE THE DAY PRIOR, AND FOUND NO MALFUNCTION. THERE IS NO FURTHER INFORMATION ON THE PATIENTS' CONDITION OR DETAILED INFORMATION ON THE KIND OF PATIENT INJURY. IT SHOULD BE NOTED THAT THE MICROSCOPE AT THE HOSPITAL WAS INSTALLED IN 1999. THE DEVICE WAS USED FOR 10 YEARS WITH NO INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISU 200 ON S8 STAND OPHTHALMIC SURGICAL MICROSCOPE EPT CARL ZEISS SURGICAL, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other