BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.3 MM X 403 MM ULTRASOUND PROBE

    MDR report key: 2495410 · Received March 19, 2012

    Report

    Report Number
    3005099803-2012-00719
    Event Type
    Injury
    Date Received
    March 19, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FFK
    PMA / PMN Number
    K012445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED DURING A PCNL PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR A 2.5CM STONE WITHIN THE KIDNEY. DURING THE PCNL PROCEDURE , THE LITHOCLAST ULTRASOUND PROBE BROKE MIDWAY ALONG THE LENGTH OF THE PROBE. THE PROBE BROKE INTO 2 PIECES, ONE OF WHICH FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED USING A 3 PRONGED GRASPER. A SECOND OF THE SAME LITHOCLAST ULTRASOUND PROBE WAS USED ALONG WITH THE SAME CONSOLE, HAND PIECE, AND FOOT PEDAL TO COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT IS OVER 18 AND THE PATIENT'S CONDITION IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.3 MM X 403 MM ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC - MARLBOROUGH M0068407160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention