BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEISS

    MDR report key: 770879 · Received August 11, 2006

    Report

    Report Number
    2431026-2006-00010
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Date of Event
    June 8, 2006
    Report Date
    August 9, 2006
    Manufacturer
    CARL ZEISS SURGICAL
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED IN 2006. DURING EXPLORATORY TYMPANOTOMY, THE MICROSCOPE SUDDENLY LOST POWER. THE SURGERY WAS CANCELLED AND RESCHEDULED. BIOMEDICAL FOUND THAT POWER FAILURE CAUSED BY A BLOWN FUSE THAT COULD NOT BE CHANGED IN THE OPERATING ROOM. THE POWER CORD WAS CHECKED, BUT FOUND NO DEFECTS. THE MICROSCOPE WAS REPAIRED AND RETURNED TO SERVICE. FDA FILED A MEDWATCH REPORT AND SENT TO "CARL ZEISS MICROIMAGING, INC.."FIFTEN DAYS LATER IN 2006, CARL ZEISS SURGICAL, THE MAKER OF THE MICROSCOPE, BECAME AWARE OF THE EVENT AND IMMEDIATELY OPENED AN INVESTIGATION. THE INVESTIGATION REVEALED THAT THE HOSP DID NOT PURCHASE THE MICROSCOPE FROM CARL ZEISS SURGICAL. THE SYSTEM IS OLD, AND CARL ZEISS SURGICAL HAS NEVER SERVICED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEISS MICROSCOPE, SURGICAL EPT CARL ZEISS SURGICAL OPMI 11/S21 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other