BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2 LASER, SHARPLAN

    MDR report key: 65320 · Received July 26, 1996

    Report

    Report Number
    65320
    Event Type
    Malfunction
    Date Received
    July 26, 1996
    Date of Event
    July 19, 1996
    Report Date
    July 26, 1996
    Manufacturer
    SHARPLAN LASER, INC.
    Product Code
    HHR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE INVOLVING BILATERAL SALPINGOSTOMIES AND LYSIS OF PELVIC ADHESIONS, THE CO2 LASER CONTINUED TO FIRE AFTER THE PEDAL WAS NO LONGER DEPRESSED. THERE WAS NO PT INJURY. DISTRIBUTOR NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO2 LASER, SHARPLAN SAME HHR SHARPLAN LASER, INC. 1075 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other