BEUDAMED
    FDA Adverse Event Death Summary report: N

    KARL STORZ CALCUTRIPT

    MDR report key: 42532 · Received October 9, 1996

    Report

    Report Number
    2020550-1996-00026
    Event Type
    Death
    Date Received
    October 9, 1996
    Date of Event
    July 25, 1995
    Report Date
    October 7, 1996
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    FFK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A BLADDER STONE FRAGMENTING PROCEDURE, DEVICE WAS USED. PT EXPIRED 36 HRS LATER. AUTOSPY REVEALED 2 PERFORATIONS ON THE PT'S BLADDER WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CALCUTRIPT ELECTRO-HYDRAULIC LITHOTRIPTOR FFK KARL STORZ GMBH & CO. 27080C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death