BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 24845972 · Received April 11, 2026

    Report

    Report Number
    3005099803-2026-01324
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 1, 2026
    Report Date
    April 10, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729804932
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT BLOCK D4, H4: THE COMPLAINT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6 (DEVICE CODES): IMDRF DEVICE CODE A140803 CAPTURES THE REPORTABLE EVENT OF DEVICE INABILITY TO IRRIGATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A ENDOSTAT III RF GENERATOR WAS USED DURING AN UNKNOWN DATE. IT WAS NOTICED THAT THE CASSETTE USED FOR IRRIGATION FLOW DID NOT FUNCTION PROPERLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912814 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00540200 08714729804932

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown