BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYONICS

    MDR report key: 313183 · Received January 19, 2001

    Report

    Report Number
    313183
    Event Type
    Other
    Date Received
    January 19, 2001
    Date of Event
    January 5, 2001
    Report Date
    January 18, 2001
    Manufacturer
    SMITH & NEPHEW DYONICS
    Product Code
    FCR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT DIRECT LARYNGOSCOPY WITH VOCAL CORD BIOPSY DUE TO ENDOLARYNGEAL LESIONS. THE LESION WAS PHOTO DOCUMENTED BY PASSING THE 4MM NASAL TELESCOPE THROUGH THE DIDO LARYNGOSCOPE. LIGHT CORD CONNECTION TO SCOPE WAS "HOT". AT CONCLUSION OF THE PROCEDURE, THE ROOM LIGHTS WERE BRIGHTENED AND DRAPES WERE REMOVED, IT BECAME EVIDENT THAT THE PT SUSTAINED A PARTIAL THICKNESS BURN TO THE NASAL TIP SKIN. NO OTHER INJURY WAS IDENTIFIED. SILVADENE CREAM WAS THEREAFTER APPLIED TO THE AREA. FINDINGS AND MANAGEMENT OF THIS COMPLICATION WAS FULLY DISCUSSED WITH PT AND PT'S SPOUSE. PT WILL BE FOLLOWED UP BY MD IN OFFICE. MD WAS NEW TO THIS HOSP AND WAS UNAWARE THAT HOSP WAS ONLY "HOT" LIGHT SOURCES IN THE OPERATING ROOM. THIS LIGHT SOURCE WAS COMPARED TO A SECOND LIKE LIGHT SOURCE AND WAS FELT TO BE WARMER THAN USUAL AT CONNECTOR TO SCOPE. BIOMEDICAL ENGINEER EXAMINED DEVICE AND FOUND NO DEFECT OR PROBLEM WITH EQUIPMENT. DYONICS REP CONTACTED AND, AFTER SIGNING A RELEASE FORM, TOOK THE EQUIPMENT FOR EVALUATION ON 01/08/2001, OBSERVED NO PROBLEMS ON INITIAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679 DYONICS FO LIGHT SOURCE FCR SMITH & NEPHEW DYONICS ABI 11 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other