BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERCHTOLD CORP, CHROMOPHARE SUGICAL LIGHTING

    MDR report key: 1807529 · Received August 13, 2010

    Report

    Report Number
    MW5017110
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING EXCISION OF LEFT SUBMANDIBULAR GLAND BY THE SURGEON IN THE OPERATING ROOM FOR DIAGNOSIS OF LEFT SUBMANDIBULAR SIALADENITIS, A PART FELL FROM THE ELBOW ON THE SURGICAL SPOTLIGHT HINGE. ONE PART FELL TO THE FOOT OF THE OPERATING ROOM TABLE, AND ANOTHER PIECE HIT THE SURGEON ON THE HEAD, THEN LANDED IN THE PT'S OPEN WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERCHTOLD CORP, CHROMOPHARE SUGICAL LIGHTING SURGICAL LIGHTING SYSTEM FSY BERCHTOLD CORP. CHROMOPHARE

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other