BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE CEILING MOUNT MICROSCOPE SYSTEM

    MDR report key: 380732 · Received February 28, 2002

    Report

    Report Number
    1937051-2002-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2002
    Date of Event
    January 7, 2002
    Report Date
    February 28, 2002
    Manufacturer
    GLOBAL SURGICAL CORP.
    Product Code
    HRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CEILING MOUNTED MICROSCOPE WAS BEING MOVED INTO ITS STORAGE POSITION WHEN THE MICROSCOPE FELL TO THE FLOOR. THERE WERE NO INJURIES OR PTS INVOLVED. THE MOUNTING POST ASSEMBLY THAT SECURED THE MICROSCOPE ASSEMBLY TO THE CEILING WAS RETURNED AND EVALUATED BY THE MFR. EXAMINATION OF THE 2 SETSCREW MARKS ON THE SHAFT INDICATES THAT THE POST WAS NOT FULLY INSTALLED INTO ITS MOUNT DURING THE ORIGINAL ASSEMBLY. SECONDARY SETSCREW MARKS ON THE SHAFT INDICATE THAT THE SETSCREWS WERE RE-TIGHTENED AT SOME POINT, WITH THE SHAFT UN-THREADED BY ABOUT ONE ROTATION. THE DESIGN OF THIS DEVICE WAS CHANGED IN MAY OF 1999. THE ASSEMBLY IS NOW DRILLED AND PINNED, THUS REPLACING THE SET SCREWS WITH 2 DOWEL PINS THAT PREVENT THE ASSEMBLY FROM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE CEILING MOUNT MICROSCOPE SYSTEM DENTAL MICROSCOPE HRM GLOBAL SURGICAL CORP. M 705C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA