BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA PULSE ID

    MDR report key: 24678210 · Received March 24, 2026

    Report

    Report Number
    2124215-2026-16199
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729978688
    PMA / PMN Number
    K210925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING AND NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF " FIBER BREAK" 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 THAT, THE FIBER SHOULD NOT BE CLAMPED WITH FORCEPS OR OTHER SECURING INSTRUMENTS AS IT COULD RESULT IN FIBER DAMAGE OR BREAKAGE. 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 URETEROSCOPY, THE FIBER BROKE AND STOPPED WORKING. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING URETEROSCOPY, THE FIBER BROKE AND STOPPED WORKING. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275225 FLEXIVA PULSE ID POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006L8406920 0037328858 08714729978688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown