BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLIMLINE 200

    MDR report key: 494077 · Received November 7, 2003

    Report

    Report Number
    2914019-2003-00016
    Event Type
    Death
    Date Received
    November 7, 2003
    Date of Event
    October 1, 2003
    Report Date
    November 5, 2003
    Manufacturer
    LUMENIS, LTD.
    Product Code
    LNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LASER DELIVERY FIBER BROKE INSIDE THE PT DURING A UROLOGICAL PROCEDURE TO REMOVE A HARD KIDNEY STONE. THE PROCEDURE LASTED 4.5 HOURS, INCLUDING: THE DR SPENT 2 HOURS WORKING ON THE STONE WHICH WAS PARTIALLY DESTROYED BEFORE THE REMAINDER OF THE STONE WAS PUSHED OUT OF THE URETER INTO THE KIDNEY CORTEX, AND THE DR SPENT 2 HOURS TRYING TO RETRIEVE THE TIP OF THE LASER FIBER THAT HAD BROKEN OFF (NOTE: AT ONE POINT, THE DR HAD THE TIP IN A GRASPER IN THE URETER, BUT THEN LOST IT. ALL IRRIGATION FLUID WAS FILTERED, BUT THE TIP WAS NOT FOUND. THE PT'S BLOOD PRESSURE WAS LABILE AND A RETROPERITONEAL BLEED WAS SEEN. THEN OVER THE NEXT 7 DAYS, THE PT ENTERED RENAL FAILURE, AND THEN SYSTEM FAILURE, AND THEN SUBSEQUENTLY DIED. A REQUEST FOR THE RETURN OF THE FIBER FOR EXAMINATION BY LUMENIS HAS BEEN MADE, BUT THE FIBER HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE 200 FIBERS LNK LUMENIS, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| R