BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERATION MICROSCOPE OMS-90

    MDR report key: 523765 · Received February 10, 2004

    Report

    Report Number
    9614661-2004-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2004
    Report Date
    February 10, 2004
    Manufacturer
    TOPCON CORP.
    Product Code
    HRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TOPCON REC'D A SINGLE REPORT FROM A DISTRIBUTOR THAT THE SECOND ARM OF TOPCON'S OMS-90 OPERATION MICROSCOPE DROPPED DOWN TO THE LOWEST POSITION BY ITSELF. AS IT WAS BEFORE THE OPERATION, NO HARM TO ANY PERSON OCCURRED AS A RESULT OF THIS INCIDENT. TOPCON'S REP CONVEYED THIS INFO TO HEADQUARTERS IN TOKYO IN A REPORT DATED IN 2004. THIS WAS THE FIRST REPORT OF ANY SUCH MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERATION MICROSCOPE OMS-90 SURGICAL MICROSCOPE HRM TOPCON CORP. OMS-90 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *