BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI PENTERO

    MDR report key: 2021327 · Received February 8, 2011

    Report

    Report Number
    9615010-2011-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 5, 2010
    Report Date
    February 9, 2011
    Manufacturer
    CARL ZEISS SURGICAL GMBH
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM EXPERIENCED AN ELECTRICAL MALFUNCTION. AS A RESULT, AND IN ACCORDANCE WITH ITS INTENDED FUNCTION, THE SYSTEM LOCKS (BRAKES) WERE ACTIVATED. THE OPERATOR'S MANUAL INDICATES THAT THE LOCKS (BRAKES) CAN BE OVERRIDEN BY THE OPERATOR BY HAND, HOWEVER, THE SURGEON EITHER WAS NOT AWARE OF THIS EMERGENCY PROCEDURE OR DID NOT CHOOSE TO USE THIS PROCEDURE. THE SYSTEM WAS EVALUATED BY A SERVICE TECH, FOUND THE SOURCE OF THE ELECTRICAL MALFUNCTION AND REPAIRED IT. THE SERVICE TECH CONFIRMED THAT THE EMERGENCY FUNCTION WAS IN PROPER WORKING ORDER.

    Description of Event or Problem · 1

    DURING A NEUROSURGERY, CLIPPING OPERATION WHEREIN THE OPMI PENTERO SURGICAL MICROSCOPE WAS IN USE, THE SYSTEM DETECTED A MALFUNCTION. THE MALFUNCTION CAUSED THE JOINTS (BRAKES) OF THE SUSPENSION SYSTEM WHICH HOLDS THE HEAD OF THE MICROSCOPE TO LOCK. AS A RESULT OF THE SYSTEM BEING LOCKED, THE SURGEON WAS NOT ABLE TO CONTROL THE POSITIONING OF THE HEAD OF THE MICROSCOPE. THE SURGEON HAD TO MOVE THE PT'S BED IN ORDER TO CHANGE THE SURGICAL FIELD OF VIEW. THE SURGERY WAS COMPLETED WITHOUT INCIDENT; THE PT WAS NOT HARMED. HOWEVER, THE DURATION OF THE SURGERY WAS EXTENDED DUE TO THE INCIDENT.

    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