BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COHERENT VP SELECT

    MDR report key: 2442935 · Received February 3, 2012

    Report

    Report Number
    2442935
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 12, 2012
    Report Date
    February 3, 2012
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE LASER LITHOTRIPSY PROCEDURE, THE LASER FIBER SNAPPED AND INJURED THE SURGEON'S RIGHT HAND. A WHITE LUMP APPROX 1MM APPEARED ON HIS HAND. SURGEON REFUSED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHERENT VP SELECT LASER, SURGICAL GEX LUMENIS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *