BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPLAN

    MDR report key: 613082 · Received May 27, 2005

    Report

    Report Number
    613082
    Event Type
    Malfunction
    Date Received
    May 27, 2005
    Date of Event
    May 26, 2005
    Report Date
    May 27, 2005
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS PREPPED AND PLACE ON THE OR TABLE FOR THE PROCEDURE. THE POWER ON THE LASER WAS SET AT 5 WATTS AS PER THE SURGEON'S ORDER. THE POWER WAS NOT WHAT THE SURGEON EXPECTED(BARELY ENOUGH TO CHAR THE TONGUE BLADE). THERE WAS ALSO A DELAY IN THE DELIVERY OF POWER. THE SURGEON DID NOT WANT TO INCREASE THE POWER AS THE SURGEON WAS CONCERNED THAT A RANGE OF 7-10 WATTS WOULD BE TOO MUCH AND COULD CAUSE INJURY. THE SURGEON WAS NOT SATISFIED WITH THE PERFORMANCE OF THE LASER AND CANCELLED THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. A REQUEST HAS BEEN MADE TO THE MANUFACTURER FOR REPAIR OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPLAN CARBON DIOXIDE SURGICAL LASER GEX LUMENIS, INC. 150XJ *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR