BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOCLAST ULTRASOUND PROBE

    MDR report key: 1325257 · Received February 26, 2009

    Report

    Report Number
    3005099803-2008-02970
    Event Type
    Injury
    Date Received
    February 26, 2009
    Date of Event
    August 24, 2007
    Report Date
    August 24, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K973788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. BROKEN PROBES ARE THE RESULT OF THE USER PLACING SIDE LOADS ON THE PROBE DURING USE.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2008-02974 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HALFWAY THROUGH A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE PROBE BROKE WHILE INSIDE THE SCOPE. THE PHYSICIAN THEN USED ANOTHER PROBE, WHICH ALSO BROKE. THE PROCEDURE WAS NOT COMPLETED BECAUSE THERE WERE NO OTHER PROBES AVAILABLE. THERE WERE REPORTEDLY NO COMPLICATIONS TO THE PATIENT.

    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 53 YR Required Intervention