BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWISS LITHOCLAST MASTER ULTRASONIC PROBE

    MDR report key: 1656894 · Received April 9, 2010

    Report

    Report Number
    3004096429-2010-00001
    Event Type
    Injury
    Date Received
    April 9, 2010
    Date of Event
    March 19, 2010
    Report Date
    April 8, 2010
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFORMATION REPORTED, THIS CASE DOESN'T SEEM TO BE RELATED TO A FAILURE OF THE DEVICE. THIS WARMING OF THE PROBE HAS BEEN CLEARLY IDENTIFIED DURING THE RISK ANALYSIS AND INDICATED IN THE USER'S MANUAL. EMS HAS REQUESTED FURTHER INFORMATION.

    Description of Event or Problem · 1

    (B) (6) HAS REPORTED TO EMS ON THE 19TH OF MARCH THAT SISTER (B) (6) FROM THE (B) (6) HOSPITAL (B) (6) REPORTED TO (B) (6) THAT DURING THE USE OF THE LITHOCLAST MASTER, ONE OF THE THEATRE STAFF WAS RECENTLY BURNT FROM THE ULTRASOUND PROBE. ACCORDING TO THE INFORMATION, FOLLOWING A DIFFICULT CASE ON A HARD STONE, THE PROBE AND HANDPIECE WAS REMOVED FROM THE PATIENT AND HANDED TO THE ASSISTANT WHO GRASPED THE PROBE AND WAS IMMEDIATELY BURNT BECAUSE IT HAD BECOME VERY HOT. ON THE 26TH OF MARCH, (B) (6) INDICATED TO US BY PHONE THAT THEY WERE WAITING TO RECEIVE A REPORT OF (B) (4) AND WOULD TRY TO GET MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWISS LITHOCLAST MASTER ULTRASONIC PROBE ULTRASONIC LITHOTRIPTOR FFK E.M.S. ELECTRO MEDICAL SYSTEMS S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other