BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOCLAST ULTRASOUND PROBE

    MDR report key: 1326117 · Received February 26, 2009

    Report

    Report Number
    3005099803-2008-04115
    Event Type
    Injury
    Date Received
    February 26, 2009
    Date of Event
    April 16, 2007
    Report Date
    April 16, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K973788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVALUATION HAS NOT BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE PROBE BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 M0068407150

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention