BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI 1-FC ON 1.85M FLOOR STAND

    MDR report key: 3750466 · Received January 31, 2014

    Report

    Report Number
    9615010-2014-00004
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 30, 2014
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    EPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EXAMINED THE MICROSCOPE AND FOUND THE WEIGHT SUSPENSION STRAP, THAT COUNTER BALANCES THE WEIGHT OF THE MICROSCOPE AND SUSPENSION ARM, HAD BROKE. THE FSE FOUND THAT THE SAFETY RING SETTING WAS NOT USED DURING PT EXAMINATION WHICH WOULD HAVE LIMITED THE DOWNWARD MICROSCOPE MOVEMENT. THE FSE WAS NOT ABLE TO REPAIR THE 30 YR OLD FLOOR STAND WHICH IS NO LONGER MANUFACTURED OR SERVICED BY ZEISS. THE MFR ISSUED A WRITTEN STATEMENT TO USER FACILITY TO NO LONGER USE THE STAND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE POSITIONING THE OPMI 1-FC MICROSCOPE TO EXAMINE A PT'S EAR THE MICROSCOPE DRIFTED DOWN AND MADE CONTACT WITH THE PT. THERE WAS A SMALL LUMP AND BRUISE ON THE PT'S HEAD. THERE WAS NO MEDICAL INTERNATIONAL REQUIRED FOR THE PT OTHER THAN AN ICE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67393 OPMI 1-FC ON 1.85M FLOOR STAND MICROSCOPE, SURGICAL, GENERAL & PLA EPT CARL ZEISS MEDITEC AG OPMI 1-FC NA

    Patients

    Seq Age Sex Outcome Treatment
    1