BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24912641 · Received April 17, 2026

    Report

    Report Number
    2955842-2026-21913
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 14, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS FIRST IDENTIFIED INTRAOPERATIVELY, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. TO ADDRESS THE PROBLEM, A BACKUP INSTRUMENT WAS USED. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THE INCIDENT. THE SOURCE COULD NOT RECALL WHETHER THE BLADES OF THE SCISSORS WERE BENT, NOR WHETHER THE ISSUE INVOLVED THE BLADES BEING STUCK IN AN OPEN OR CLOSED POSITION. THE INSTRUMENT IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT MOVABLE PART HAS BECOME STUCK IN A BENT POSITION. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488133 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K11250320 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1