BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 974255 · Received May 21, 2007

    Report

    Report Number
    2020550-2007-00013
    Event Type
    Other
    Date Received
    May 21, 2007
    Date of Event
    March 20, 2007
    Report Date
    May 18, 2007
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    NCV
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING STONE FRAGMENTATION PROCEDURE, USING A LITHOTRIPSY MACHINE, THE UNIT STOPPED WORKING. THE UNIT DELIVERED 2,000 SHOCKWAVES, BUT THERE WAS NO CHANGE IN PT CONDITION - NO STONES WERE FRAGMENTED. THE UNIT STOPPED WORKING BY ITSELF AT 2,000; HOSP IS RESCHEDULING PT. THERE WAS NO INJURY TO THE PT OR OR PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LITHOTRIPTOR - SLX NCV STORZ MEDICAL AG 3891 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other