BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTREE CEILING MOUNT MICROSCOPE SYSTEM

    MDR report key: 399756 · Received June 11, 2002

    Report

    Report Number
    1937051-2002-00002
    Event Type
    Malfunction
    Date Received
    June 11, 2002
    Date of Event
    May 3, 2002
    Report Date
    June 2, 2002
    Manufacturer
    GLOBAL SURGICAL CORP.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE CO RECEIVED A CALL FROM A CUSTOMER THAT THEIR CEILING MOUNTED MICROSCOPE FELL FROM THE CEILING. IT WAS INITIALLY REPORTED THAT NO ONE WAS INJURED. SUBSEQUENT REPORTS INDICATED THAT NO ONE WAS INJURED. SUBSEQUENT REPORTS INDICATED THAT IT HAD FALLEN ON A PT'S SHOULDER AND THAT PT HAD DEVELOPED A BRUISE. THE PT REFUSED ANY MEDICAL ATTENTION. AN ON-SITE TECHNICAL EVALUATION 4 DAYS LATER FOUND THAT THE COLUMN HAD BEEN IMPROPERLY INSTALLED IN ITS CLAMP. MECHANICAL MARKINGS INDICATED THAT COLUMN HAD BEEN ENGAGED INTO THE CLAMP ONLY ABOUT 1.5". THE DESIGN AND INSTALLATION INSTRUCTIONS INDICATE THAT THE COLUMN BE FULLY ENGAGED IN THE CLAMP AT 3". EXAMINATION OF A SECOND SYSTEM AT THE CUSTOMER'S SITE REVEALED THAT IT TO HAD BEEN IMPROPERLY INSTALLED IN THE SAME MANNER. BOTH SYSTEMS WERE THEN REINSTALLED PROPERLY INTO THE CLAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTREE CEILING MOUNT MICROSCOPE SYSTEM DENTAL MICROSCOPE EPT GLOBAL SURGICAL CORP. M 704CL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA