BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPLAN

    MDR report key: 17386 · Received September 14, 1994

    Report

    Report Number
    17386
    Event Type
    Injury
    Date Received
    September 14, 1994
    Date of Event
    September 2, 1994
    Report Date
    September 13, 1994
    Manufacturer
    SHARPLAN LASERS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SCHEDULED PT FOR LASER SURGERY CANCELLED BECAUSE THE LASER DID NOT TURN ON WHEN KEY TURNED IN THE IGNITION. BIOMED DEPT REPLACED DEFECTIVE ON/OFF SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPLAN SURGICAL LASER CO. GEX SHARPLAN LASERS, INC. 1060

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization PT SCHEDULED FOR SAME PROCEDURE, 9/19/94.