BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASE MODEL 1100-010

    MDR report key: 369513 · Received December 26, 2001

    Report

    Report Number
    2183911-2001-00002
    Event Type
    Other
    Date Received
    December 26, 2001
    Date of Event
    December 4, 2001
    Report Date
    December 20, 2001
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE SALES REP. REPORTED TO CLARUS MEDICAL 2 DAYS POST EVENT THAT THE PHYSICIAN USING THE DEVICE WAS INJURED WHILE USING THE DEVICE: THE INJURY WAS A MINOR BURN ON THE HAND CAUSED BY LABOR ENERGY RELEASED BY A BROKEN LASER FIBER. THE DEVICE WAS REPLACED AND THE CASE WAS COMPLETED. THE DEVICE WAS RECEIVED BY CLARUS MEDICAL 1 WEEK POST EVENT AND WAS INSPECTED FOR DAMAGE. THE FIBER WAS BROKEN AT THE PROXIMAL END OF THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58413 LASE MODEL 1100-010 ENDOSCOPIC DISCECTOMY DEVICE GEX CLARUS MEDICAL, LLC. 1100-010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other