BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA PULSE ID

    MDR report key: 24415309 · Received February 23, 2026

    Report

    Report Number
    2124215-2026-09823
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 26, 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. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. A LABELLING 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. A RISK REVIEW WAS PERFORMED AND CONFIRMED THAT THE EVENT OF THE FIBER BREAKING 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. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE "UNABLE TO EXCLUDE DEVICE PROBLEM" HAS BEEN ASSIGNED AS THE MOST PROBABLE CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE AS THE PHYSICIAN WAS ADVANCING IT INTO THE SCOPE. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE AS THE PHYSICIAN WAS ADVANCING IT INTO THE SCOPE. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450066 FLEXIVA PULSE ID POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006L8406920 0037075171 08714729978688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown