BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWISS LITHOCLAST

    MDR report key: 645311 · Received November 4, 2005

    Report

    Report Number
    8030987-2005-00002
    Event Type
    Death
    Date Received
    November 4, 2005
    Report Date
    November 4, 2005
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Product Code
    FFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DIED FOLLOWING SURGERY TO REMOVE A BLADDER STONE USING A PNEUMATIC INTRACORPORAL LITHOTRIPTER. ACCORDING TO A VERBAL REPORT FROM THE BIOMED DEPARTMENT OF THE MED CTR, THE BLADDER WAS PUNCTURED DURING THE PROCEDURE EVALUATION OF THE DEVICE BY MANUFACTURER HAS IDENTIFIED A MINOR MALFUNCTION IN THAT THE SOLENOID HAD A SLOW LEAK CAUSING THE AIR PRESSURE TO SLOWLY DECLINE. THERE IS CURRENTLY NO INDICATION THAT THE MINOR MALFUNCTION OF THE SOLENOID WAS RELATED TO THE BLADDER PUNCTURE. INVESTIGATION IS CURRENTLY ON-GOING. THE DEVICE WILL BE RETURNED TO EMS HEADQUATERS AND AN INDEPTH INVESTIGATION WILL BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWISS LITHOCLAST ENDOSCOPIC INTRACORPOREAL PNEUMATIC LITHOTRIPTER FFK E.M.S. ELECTRO MEDICAL SYSTEMS S.A. FT-103BA *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death