BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMENIS SLIMLINE 200 FOR COHERENT 200

    MDR report key: 622094 · Received July 18, 2005

    Report

    Report Number
    622094
    Event Type
    Death
    Date Received
    July 18, 2005
    Date of Event
    October 2, 2003
    Report Date
    July 15, 2005
    Manufacturer
    LUMENIS, INC.
    Product Code
    MVF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR NEPHROLITHIASIS. IN 2003, PT UNDERWENT A RIGHT URETEROSCOPY, CYSTOSCOPY AND LASER LITHOTRIPSY. DURING THE PROCEDURE, PT WAS FOUND TO HAVE AN IMPACTED, DENSE, HARD STONE. A FRAGMENT OF THE FIBER BROKE OFF AND MOVED FORWARD (2.5CM 200 HOLMIUM) AND DESPITE MULTIPLE ATTEMPTS, RETRIEVAL WAS UNSUCCESSFUL AND THE FIBER TIP WAS RETAINED. PT SUBSEQUENTLY WAS DIAGNOSED WITH A RETROPERITONEAL BLEED AND EXPIRED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS SLIMLINE 200 FOR COHERENT 200 FIBER DELIVERY DEVICE MVF LUMENIS, INC. * 072601

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| O| R