BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA PULSE ID

    MDR report key: 24868061 · Received April 14, 2026

    Report

    Report Number
    2124215-2026-20008
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729978718
    PMA / PMN Number
    K210925
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE PRODUCT RECORD REVIEW (PRR) RESULTS DETAILED IN THE PRR TABLE DID NOT DETERMINE THE PROBABLE CAUSE OF COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "DETACHED/BROKE INSIDE PATIENT" WAS DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. A LABELING REVIEW WAS PERFORMED ON THE DEVICE INSTRUCTIONS FOR USE (IFU). THE IFU CITED TO CAREFULLY INSPECT THE FIBER FOR KINKS, PUNCTURES, FRACTURES, A BROKEN TIP (FLAT OR BALL), JACKET/FIBER OR OTHER PARTICULATES/PIECES, OR OTHER VISUAL DAMAGE. IF THE FIBER APPEARS DAMAGED, DO NOT USE THE DEVICE. IF IT IS AN UNUSED DEVICE, RETURN IT TO THE MANUFACTURER FOR A REPLACEMENT. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE "CAUSE NOT ESTABLISHED" HAS BEEN ASSIGNED AS THE MOST PROBABLE CAUSE FOR THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS BROKEN IN THE RENAL CALYX. IT WAS NOTED THAT THE LASER TIP WAS REMOVED INTACT USING A BASKET. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS BROKEN IN THE RENAL CALYX. IT WAS NOTED THAT THE LASER TIP WAS REMOVED INTACT USING A BASKET. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101024 FLEXIVA PULSE ID POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006L8406960 0037599885 08714729978718

    Patients

    Seq Age Sex Outcome Treatment
    1