BEUDAMED
    FDA Adverse Event Death Summary report: N

    KARL STORZ TUUL UNIT

    MDR report key: 307957 · Received December 7, 2000

    Report

    Report Number
    MW4002902
    Event Type
    Death
    Date Received
    December 7, 2000
    Date of Event
    November 16, 2000
    Report Date
    November 29, 2000
    Manufacturer
    CYBERSONICS, INC.
    Product Code
    FEO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A PERCUTANEOUS NEPHROSCOPY PROCEDURE. THE KARL STORZ ULTRASONIC LITHOTRIPTOR UNIT WAS NOT TESTED PRIOR TO THE PROCEDURE AND WAS FOUND NOT TO BE FUNCTIONING. THE PROCEDURE WAS DELAYED 25 MINS AND THE LITHOTRIPTOR WAS REPLACED WITH A HOLMIUM LASER. 2 DAYS LATER THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ TUUL UNIT ULTRASONIC LITHOTRIPTOR FEO CYBERSONICS, INC. 27085K *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death