BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOCLAST ULTRASOUND PROBE

    MDR report key: 1324989 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02740
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    June 15, 2007
    Report Date
    June 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K973788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWS NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. CUSTOMER COMPLAINT CONFIRMED. PROBE IS BROKEN. PROBE BREAKAGE IS THE RESULT OF THE USER BENDING THE PROBE DURING USE.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE THIRD OF THREE DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #300509980320082738 AND #300509980320082739 FOR DESCRIPTIONS OF THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE FIRST PROBE USED BROKE. THE PHYSICIAN USED A SECOND AND THIRD PROBE, AND EACH OF THESE BROKE TOO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH 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 0009152931

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention