BEUDAMED
    FDA Adverse Event Summary report: N

    FIBERTOME - 4060N

    MDR report key: 14133 · Received April 8, 1994

    Report

    Report Number
    1037955-1994-00001
    Date Received
    April 8, 1994
    Date of Event
    March 8, 1994
    Report Date
    March 25, 1994
    Manufacturer
    DORNIER MEDIZINTECHNIK GMBH
    Product Code
    LWX
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AAT MID-PROCEDURE, THE LASER STOPPED WORKING TO SPECIFICATION. PT RETURNED FOUR DAYS LATER FOR COMPLETION OF PROCEDURE. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERTOME - 4060N LASER LWX DORNIER MEDIZINTECHNIK GMBH 4060N NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *