BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPLAN

    MDR report key: 229815 · Received June 29, 1999

    Report

    Report Number
    MW1016636
    Event Type
    Malfunction
    Date Received
    June 29, 1999
    Date of Event
    April 23, 1999
    Manufacturer
    SHARPLAN LASERS INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER TESTED PRIOR TO LAPAROSCOPIC PROCEDURE. DURING PROCEDURE BEAM WAS NOT ALIGNED THEN DISAPPEARED. BIPOLAR CAUTERY USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPLAN CO2 LASER GEX SHARPLAN LASERS INC. 1055 S *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR