BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLIMLINE 1000

    MDR report key: 709506 · Received May 8, 2006

    Report

    Report Number
    2914019-2006-00041
    Event Type
    Death
    Date Received
    May 8, 2006
    Date of Event
    April 4, 2006
    Report Date
    May 8, 2006
    Manufacturer
    *
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED TO LUMENIS IN 2006. THE PATIENT UNDERWENT A BLADDER TUMOR RESECTION AND ABLATION THAT WAS INITIATED WITH A STANDARD ELECTRODE PROCEDURE LOOP AND COMPLETED WITH A LUMENIS SLIMLINE 1000 FIBER; THE PROCEDURE WAS SUCCESSFUL. AFTER THE BLADDER TUMOR RESECTION/ABLATION THE PATIENT UNDERWENT HOLAP WITH A LUMERIS DUE TOME 550 FIBER AND THE HOLAP WAS ALSO CONSIDERED A SUCCESS. AFTER THE INCIDENT THE PATIENT EXPERIENCED COMPARTMENTAL SYNDROME (FLUID ABSORPTION) WHICH WAS THE CAUSE OF DEATH. THE PATIENT WAS PLACED ON LIFE SUPPORT AND EXPIRED APPROXIMATELY 2 DAYS AFTER THE INCIDENT. THE PHYSICIAN INDICATED THAT THE INCIDENT WAS NOT RELATED TO THE TWO LUMERIS FIBERS. THE FIBERS WERE NOT RETURNED TO LUMERIS FOR EVALUATION AND THE ENDUSER DID NOT PROVIDE THE LOT NUMBERS OF THE FIBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE 1000 SURGICAL FIBER GEX * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death