BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWISS LITHOCLAST MASTER

    MDR report key: 785404 · Received November 9, 2006

    Report

    Report Number
    3004096429-2006-00001
    Event Type
    Death
    Date Received
    November 9, 2006
    Date of Event
    September 20, 2005
    Report Date
    September 11, 2006
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Product Code
    FFK
    PMA / PMN Number
    K012445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING SHIPPED TO EMS AND WILL BE HELD THERE IN QUARANTINE FOR PUBLIC ATTORNEY'S INVESTIGATION. EMS WILL UNDERTAKE INVESTIGATION OF THE DEVICE FOLLOWING THE PUBLIC ATTORNEY'S INVESTIGATION.

    Description of Event or Problem · 1

    EMS HAS BEEN INFORMED 10/11/06 BY DISTRIBUTOR OF SWISS LITHOCLAST MASTER THAT THE PUBLIC ATTORNEY, IS INVESTIGATING A CASE OF DEATH IN A HOSPITAL. THE PT PASSED AWAY IN 2006 AFTER A TREATMENT PCNL IN THE KIDNEY WITH THE SWISS LITHOCLAST MASTER. AN EXPERT OF DISTRIBUTOR INSTALLED THE DEVICE, AND ANOTHER EXPERT WAS PRESENT DURING THE OPERATION. ACCORDING TO INFO PROVIDED BY DISTRIBUTOR, THE DEVICE WAS IN PERFECT ORDER. BUT, COMPLICATION (BLEEDING) OCCURRED AFTER PERFORATION OF THE KIDNEY AND VESSELS AND THE TREATMENT HAD TO BE STOPPED. THE FOLLOWING NIGHT, AN EMERGENCY OPERATION TOOK PLACE, BUT THE PT DID NOT SURVIVE. BASED ON THE INFO PROVIDED, THE DEVICE IS NOT CONSIDERED TO HAVE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWISS LITHOCLAST MASTER ENDOSCOPIC INTRACORPOREAL LITHOTRIPTOR FFK E.M.S. ELECTRO MEDICAL SYSTEMS S.A. FT-128W *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death