BEUDAMED
    FDA Adverse Event Death Summary report: N

    LX-20 / LX-20SP

    MDR report key: 806055 · Received January 19, 2007

    Report

    Report Number
    2914019-2006-00116
    Event Type
    Death
    Date Received
    January 19, 2007
    Date of Event
    December 19, 2006
    Report Date
    January 19, 2007
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LUMENIS REP, A GOLD TIP DELIVERY DEVICE (10MM, SHORT, SMALL SPOT TIP 0.4 MM) WAS USED TOGETHER WITH THE LX-20SP LASER DEVICE DURING THE NEUTER PROCEDURE. PER THE LUMENIS REP, THE DELIVERY DEVICE WAS DISCARDED AFTER THE PROCEDURE AND WAS NOT AVAILABLE FOR ANALYSIS BY LUMENIS. AS OF 1/17/2007, THE LX-20SP DEVICE IS UNDER EVALUATION BY LUMENIS SERVICE AT THE LUMENIS SERVICE DEPOT. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 1

    A CANINE UNDERWENT A NEUTER PROCEDURE ASSISTED BY THE LX-20SP LASER IN 2006 AS PART OF A LUMENIS SALES DEMONSTRATION. THE LASER WAS UTILIZED BY THE VETERINARIAN BOTH FOR INCISIONS DURING THE NEUTER PROCEDURE AND FOR SEVERING THE ASSOCIATED ARTERY OR VESICLE. THE ARTERY WAS ALSO LIGATED (CLOSED WITH SUTURES) BY THE VETERINARIAN. AFTER THE PROCEDURE, THE CANINE WAS RELEASED HOME TO ITS OWNER AND AT APPROX 11:00 PM SAME DAY, THE OWNER CALLED THE VETERINARY CLINIC TO REPORT THAT THE CANINE WAS NOT DOING WELL. AT 2:00 AM, THE OWNER OF THE CANINE PAGED THE CLINIC AND BROUGHT THE DOG TO THE CLINIC, WHERE THE CANINE WAS PRONOUNCED DEAD. PER THE NECROPSY PERFORMED THE NEXT DAY, THE CANINE HAD BLED TO DEATH, AND THE ABDOMEN WAS FULL OF BLOOD. PER THE VETERINARIAN, IT APPEARED THAT THE SEVERED ARTERY MAY HAVE RETRACTED DOWN AND THAT WHEN SHE TIED OFF THE VESICLE, THE ARTERY MUST HAVE BEEN BELOW THE LIGATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LX-20 / LX-20SP CARBON DIOXIDE SURGICAL LASER GEX LUMENIS, LTD. ACCUNET NOVAPULSE 20W WITH NC *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death NONE REPORTED