BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REZUM

    MDR report key: 23994326 · Received January 7, 2026

    Report

    Report Number
    2124215-2026-01029
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 9, 2025
    Report Date
    March 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729992547
    PMA / PMN Number
    K190093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) K191505. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE MET WITH ALL MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF DEVICE DISPLAYS 225 DELIVERY DEVICE IS PERMANENTLY DISABLED IS DEFINED IN THE RISK DOCUMENTATION. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) K191505.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DELIVERY DEVICE WAS NOT WORKING. WHEN DEVICE WAS PLUGGED IN, IT IMMEDIATELY POPS UP ERROR 255 (DELIVERY DEVICE IS PERMANENTLY DISABLED.) DUE TO THIS EVENT THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DELIVERY DEVICE WAS NOT WORKING. WHEN DEVICE WAS PLUGGED IN, IT IMMEDIATELY POPS UP ERROR 255 (DELIVERY DEVICE IS PERMANENTLY DISABLED.) DUE TO THIS EVENT THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259603 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M006D2201-003 08714729992547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown