BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.3 MM X 403 MM ULTRASOUND PROBE

    MDR report key: 7148066 · Received December 27, 2017

    Report

    Report Number
    3005099803-2017-03908
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFK
    UDI-DI
    08714729516606
    PMA / PMN Number
    K012445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT 3005099803-2017-03909 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT TWO ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TEN MINUTES INTO THE PROCEDURE, THE FIRST ULTRASOUND PROBE (THE SUBJECT OF THIS MFR REPORT) BROKE IN HALF WHEN THE LITHOCLAST WAS AT LEVEL 90. THE SAME ISSUE HAPPENED WITH THE SECOND ULTRASOUND PROBE (MFR REPORT #3005099803-2017-03909). THE BROKEN PIECES WERE RETRIEVED FROM INSIDE THE PATIENT WITH THE USE OF A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE AND ALSO A HOLMIUM LASER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927055 3.3 MM X 403 MM ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC - SPENCER M0068407160 21188293 08714729516606

    Patients

    Seq Age Sex Outcome Treatment
    1 Other