BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPMI PENTERO

    MDR report key: 2011914 · Received February 24, 2011

    Report

    Report Number
    9615010-2011-00003
    Event Type
    Other
    Date Received
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CARL ZEISS SURGICAL GMBH
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPMI PENTERO SURGICAL MICROSCOPE CONNECTED TO A NAVIGATION SYSTEM IS REQUIRED TO BE CALIBRATED PRIOR TO USE. THE OPMI PENTERO USER MANUAL INFORMS THE USER: "BEFORE EVERY SURGERY USING A CONNECTED AND AUTHENTICATED NAVIGATION SYSTEM, THE FUNCTION AND ACCURACY OF THIS NAVIGATION SYSTEM MUST BE VERIFIED, INCLUDING VISUALIZATION IN THE DATA INJECTION MODE (E.G. FOCUSING ON A MEASURING POINT OR COMPARISON OF THE FOCUS WITH THE INSTRUMENT TO BE NAVIGATED)." IT APPEARS THAT (B)(6) DID NOT CALIBRATE THE OPMI PENTERO WITH A MICROTEK DRAPE CONNECTED TO THE NAVIGATION SYSTEM PRIOR TO USE OR FOLLOW THE INSTRUCTIONS FOR USE INDICATED ABOVE. WHEN THE CARL ZEISS MEDITEC DRAPE, WHICH HAS A FLAT PROTECTION LENS, IS USED WITH THE OPMI PENTERO SURGICAL MICROSCOPE, CORRECT DATA ON THE WORKING DISTANCE FROM THE MICROSCOPE TO THE PATIENT IS TRANSFERRED TO THE NAVIGATION SYSTEM,

    Description of Event or Problem · 1

    THE SURGEON AT (B)(6) REPORTED THAT THE NAVIGATION SYSTEM CONNECTED TO AN OPMI PENTERO SURGICAL MICROSCOPE WAS NOT WORKING PROPERLY. (B)(6) USED A MICROTEK DRAPE WITH CURVED PROTECTIVE LENS WITH THE OPMI PENTERO SYSTEM CONNECTED TO A MEDTRONIC NAVIGATION SYSTEM. IT WAS DISCOVERED THAT THE PROTECTION LENS FOR THIS DRAPE HAS AN INHERENT LEVEL OF ADDITIONAL MAGNIFICATION. THE AUTO FOCUS FEATURE OF THE OPMI PENTERO DETECTED THIS ADDITIONAL MAGNIFICATION AND COMPENSATED THE WORKING DISTANCE FROM MICROSCOPE TO PATIENT. AS THE SYSTEM (THE OPMI PENTERO CONNECTED TO THE MEDTRONIC NAVIGATION SYSTEM) WAS NOT CALIBRATED FOR THIS ADDITIONAL LENS, SKEWED DATA ON THE ACTUAL WORKING DISTANCE FROM THE MICROSCOPE TO THE PATIENT WAS TRANSFERRED TO THE NAVIGATION SYSTEM WHICH CAUSED A SHIFT IN ITS POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI PENTERO SURGICAL MICROSCOPE EPT CARL ZEISS SURGICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other