BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA PULSE ID

    MDR report key: 24899590 · Received April 16, 2026

    Report

    Report Number
    2124215-2026-20734
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729978695
    PMA / PMN Number
    K210925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PROBABLE CAUSE OF THE COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "FAILURE TO OPERATE" 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, OR OTHER DAMAGE. IF THE FIBER APPEARS DAMAGED, DO NOT USE THE DEVICE AND 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 PROCEDURE, THREE SEPARATE FIBERS WERE TRIED HOWEVER NO ENERGY WOULD PASS DOWN THE FIBER. A CONNECTION ISSUE WAS ALSO INDICATED. THE PATIENT, WHO WAS UNDER GENERAL ANESTHESIA, WAS WOKEN UP AND WILL NEED FURTHER SURGERY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE LASER. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN. DEVICE 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462513 FLEXIVA PULSE ID POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006L8406930 08714729978695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown