BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL FIBER

    MDR report key: 841236 · Received April 25, 2007

    Report

    Report Number
    2914019-2007-00014
    Event Type
    Death
    Date Received
    April 25, 2007
    Date of Event
    April 16, 2007
    Report Date
    April 25, 2007
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS HAS CONFIRMED THAT AT LEAST ONE OF THE DUOTOME FIBERS WAS DISPOSED OF BY THE ENDUSER AND WILL NOT BE AVAILABLE FOR EVAL. PER THE ENDUSER, THE PT WAS DOING WELL IN INTENSIVE CARE POST-TURP PROCEDURE DESPITE HIS COMPLICATIONS (NO DETAILS WERE PROVIDED TO LUMENIS REGARDING THESE COMPLICATIONS), AND THE CAUSE OF DEATH WAS ASPIRATION. PER THE ENDUSER, THERE WAS NO INDICATION THAT THE PT DEATH WAS RELATED EITHER TO THE LUMENIS DEVICES OR TO THE TURP PROCEDURE. IF ADD'L DETAILS ARE OBTAINED. LUMENIS WILL FILE A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    A PT WHO UNDERWENT A LASER TURP PROCEDURE IN 2007 EXPIRED. TWO DUOTOME 550 FIBERS WERE USED DURING THIS PROCEDURE. THE FIRST DUOTOME 550 FIBER LASTED UNTIL APPROX 75KJ TOTAL ENERGY. THE SECOND DUOTOME 550 FIBER WAS USED UNTIL 25KJ, AT WHICH POINT THE LASER ENERGY BEGAN TO EXIT THROUGH THE END, RATHER THAN THE SIDE OF THE FIBER. AFTER THE SECOND FIBER FAILED, THE PHYSICIAN COMPLETED THE PROCEUDRE AS A TRADITIONAL TURP WITH A RESECTION LOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL FIBER HO:YAG/ND:YAG SURGICAL LASER FIBER DELIVERY DEVICE GEX LUMENIS, LTD. DUOTOME 550 50070107

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death NONE REPORTED