BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOCLAST ULTRASOUND PROBE

    MDR report key: 1325760 · Received February 26, 2009

    Report

    Report Number
    3005099803-2008-03396
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K973788
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY, THE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. CUSTOMER COMPLAINT CONFIRMED. THE PROBE IS BROKEN IN HALF. THE INVESTIGATION DETERMINED THE PROBE BREAKAGE IS CAUSED BY A SIDE LOAD BEING APPLIED TO THE PROBE WHEN ENERGIZED. THE SIDE LOAD CAUSES THE PROBE TO CONTACT THE INTRODUCER AND BREAK.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-6521 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE PROBE BROKE IN HALF INSIDE THE SCOPE. THE SCOPE WAS PULLED OUT OF THE PATIENT WITH THE PROBE INSIDE OF IT. THEY USED A SECOND PROBE AND THAT ALSO BROKE IN HALF INSIDE THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A THIRD PROBE, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOCLAST ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC CORPORATION-SPENCER M0068407160

    Patients

    Seq Age Sex Outcome Treatment
    1