BEUDAMED
    FDA Adverse Event Death Summary report: N

    KARL STORZ CALCUTRIPT PROBE

    MDR report key: 300049 · Received October 13, 2000

    Report

    Report Number
    2020550-2000-00025
    Event Type
    Death
    Date Received
    October 13, 2000
    Date of Event
    September 6, 2000
    Report Date
    October 13, 2000
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    FFK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS NEPHROLITHOTRIPSY PROCEDURE, PT RECEIVED 42000CC FLUID IRRIGANT INTO KIDNEY. POST PROCEDURE, PT DID NOT RESUME PRIOR LEVEL OF CONSCIOUSNESS. ALTHOUGH KARL STORZ CALCUTRIPT PROBE WAS INTRODUCED INTO THE KIDNEY, DOCTOR COULD NOT SEE THE STONE WELL AND THEREFORE DID NOT ACTIVATE THE CURRENT. AUTOPSY REVEALED MULTIPLE PUNCTURE WOUNDS TO THE KIDNEY WITH ZIG ZAG TRAUMA TO KIDNEY VASCULAR BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CALCUTRIPT PROBE EHL PROBE FFK KARL STORZ GMBH & CO. 27080GA *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death