BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI PENTERO

    MDR report key: 2882890 · Received December 18, 2012

    Report

    Report Number
    9615010-2012-00017
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER CONDUCTED AN ON-SITE INSPECTION OF THE MICROSCOPE. THE EMERGENCY FUNCTIONS, COMPUTER AND MICROSCOPE HEAD, INCLUDING AXES 4/5/6, WERE DETERMINED TO BE FINE. BY DESIGN, THE MICROSCOPE STAND AXES 1/2/3 AND DRAPE PUMP WERE LOCKED DUE TO A FAILURE IN THE SUB-SYSTEM CONTAINING THE BRAKE POWER DRIVER BOARD. THE BRAKE POWER DRIVER BOARD AND DRAPE PUMP WERE REPLACED AND THE MICROSCOPE PUT BACK INTO SERVICE. IN THE USER MANUAL IT IS RECOMMENDED, IN SUCH A SITUATION, TO SWITCH THE MAIN KNOB OFF AND AS SOON THE BLUE SCREEN APPEARS (APPROXIMATELY 10 SECONDS) SWITCH THE SYSTEM BACK ON. THE MICROSCOPE FUNCTIONS (ZOOM, FOCUS, LIGHT AND MAGNETIC BRAKES) ARE AVAILABLE AFTER APPROXIMATELY 15 SECONDS. IF ONE OR MORE AXES ARE STILL BLOCKED THEN HOLD THE MICROSCOPE ON THE BODY AND POSITION IT MANUALLY TO COUNTERACT THE MAGNETIC BRAKING EFFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO AND ONE HALF HOURS INTO A CRANIAL TUMOR RESECTION NEUROLOGICAL PROCEDURE USING AN OPMI PENTERO SURGICAL MICROSCOPE, THE MICROSCOPE AXES 'LOCKED UP' AND AN ERROR MESSAGE RELATING TO THE STAND AXES AND DRAPE PUMP WAS DISPLAYED. REBOOTING THE SYSTEM DID NOT RESOLVE THE PROBLEM. THE MALFUNCTIONING MICROSCOPE WAS REPLACED WITH A SECOND OPMI PENTERO MICROSCOPE AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE ATTEMPT TO REBOOT THE SYSTEM FOLLOWED BY MICROSCOPE EXCHANGE RESULTED IN A 20-25 MINUTE DELAY IN THE SURGICAL PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1