BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLIMLINE 200

    MDR report key: 625860 · Received August 12, 2005

    Report

    Report Number
    2914019-2005-00040
    Event Type
    Death
    Date Received
    August 12, 2005
    Date of Event
    October 2, 2003
    Report Date
    August 11, 2005
    Manufacturer
    LUMENIS (ISRAEL)
    Product Code
    LNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT 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. PATIENT SUBSEQUENTLY WAS DIAGNOSED WITH A RETROPERITONEAL BLEED AND EXPIRED SEVENTEEN DAYS LATER. MEDICAL HISTORY: HYPERTENSION, COPD, ASTHMA, PERIPHERAL EDEMA. SUBSEQUENT TO EVENT PATIENT DEVELOPED: A. RESPIRATORY FAILURE REQUIRING INTUBATION, B. RENAL FAILURE AND SEPSIS REQUIRING HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE 200 FIBER LNK LUMENIS (ISRAEL) NA 072601

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R