BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REZUM

    MDR report key: 23229777 · Received October 6, 2025

    Report

    Report Number
    2124215-2025-70598
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729992547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED. G4: PMA/510(K) # FIELD ON 3500A FORM IS K190093, K191505 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM IS K190093, K191505 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE HAD TO BE DISSEMBLED BECAUSE THE NEEDLE RETRACTION BUTTON FAILED. THE EMERGENCY NOSE CONE RELEASE PIN WAS PULLED. A SECOND DEVICE WAS OPENED BUT IT PRESENTED THE SAME ISSUE. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE HAD TO BE DISSEMBLED BECAUSE THE NEEDLE RETRACTION BUTTON FAILED. THE EMERGENCY NOSE CONE RELEASE PIN WAS PULLED. A SECOND DEVICE WAS OPENED BUT IT PRESENTED THE SAME ISSUE. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2461525 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M006D2201-003 0036796824 08714729992547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown