BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE CEILING MONUNT MICROSCOPE SYSTEM

    MDR report key: 226588 · Received June 2, 1999

    Report

    Report Number
    1937051-1999-00001
    Event Type
    Other
    Date Received
    June 2, 1999
    Date of Event
    May 4, 1999
    Report Date
    May 28, 1999
    Manufacturer
    GLOBAL SURGICAL CORP.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DR WAS NEARING THE END OF A ROUTINE ROOT CANAL WHEN THE CEILNG MOUNTED MICROSCOPE BEING USED FELL FROM THE CEILING. THE DR WAS ABLE TO CATCH THE MICROSCOPE AS IT FELL; HOWEVER THE MOUNING ARM SWUNG AROUND AND CONTACTED THE PT'S FOREHEAD. THE PT RECEIVED A LACERATION APPROX 1/4" LONG THAT WAS SUBSEQUENTLY CLOSED WITH A BANDAGE. THE ROOT CANAL WAS THEN COMPLETED, WITH NO FURTHER COMPLICATIONS. THE PT DID NOT REQUIRE ANY ADDITIONAL FOLLOWUP OR MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE CEILING MONUNT MICROSCOPE SYSTEM DENTAL MICROSCOPE EPT GLOBAL SURGICAL CORP. M705C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other