BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YAG LASER PROBE

    MDR report key: 16013 · Received September 12, 1994

    Report

    Report Number
    MW1003299
    Event Type
    Malfunction
    Date Received
    September 12, 1994
    Date of Event
    June 22, 1994
    Report Date
    September 1, 1994
    Manufacturer
    SURGICAL LASER TECHNOLOGIES, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE INVOLVING THE USE OF A YAG LASER, THE TIP OF THE LASER PROBE SHEARED OFF FROM THE TIP OF THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YAG LASER PROBE LASER PROBE GEX SURGICAL LASER TECHNOLOGIES, INC. MTRL 3

    Patients

    Seq Age Sex Outcome Treatment
    1 *