BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANOVO SURGICAL SYSTEM

    MDR report key: 25345006 · Received May 31, 2026

    Report

    Report Number
    3012602431-2026-00050
    Event Type
    Injury
    Date Received
    May 31, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 31, 2026
    Manufacturer
    MOMENTIS SURGICAL LTD
    Product Code
    QNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MFR REPORT: 3014155960-2026-00001. A TRANSVAGINAL ENDOSCOPIC HYSTERECTOMY PROCEDURE WAS PERFORMED. THE ANOVO SURGICAL SYSTEM DOCKING AND VAGINAL ACCESS WERE PERFORMED AS REQUIRED, WHILE A UTERINE MANIPULATOR WITHOUT A CERVICAL CUP WAS ELECTED. DURING THE BLADDER FLAP / UTERINE CERVIX DISSECTION, DIFFICULTY WAS ENCOUNTERED IN IDENTIFYING THE DISSECTION PLANE, AS THE MANIPULATOR HAD NO CUP TO ASSIST IN IDENTIFYING THE FORNICES. AS A RESULT, DISSECTION PROCEEDED THROUGH THE BLADDER WALL AND A BLADDER INJURY WAS IMMEDIATELY IDENTIFIED. A DECISION WAS MADE TO CONVERT TO MULTIPORT ABDOMINAL ACCESS TO REPAIR THE BLADDER AND COMPLETED THE PROCEDURE. NO ERRORS, MALFUNCTIONS, OR ABNORMAL BEHAVIOR OF THE ANOVO SURGICAL SYSTEM WERE OBSERVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352482 ANOVO SURGICAL SYSTEM MOUNTABLE ELECTROMECHANICAL SURG QNM MOMENTIS SURGICAL LTD 6NE

    Patients

    Seq Age Sex Outcome Treatment
    1