BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23600000 · Received November 19, 2025

    Report

    Report Number
    2955842-2025-45714
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO REPORT OF ANY ISSUES RELATED TO NON-INTUITIVE OR CONTROLLED MOTION. THERE WERE NO VISIBLY BROKEN CABLES AT THE INSTRUMENT WRIST. IT IS UNKNOWN IF THERE WAS ANY OTHER PHYSICAL DAMAGE VISIBLE ON THE INSTRUMENT. THERE WAS SUTURE/WIRE VISIBLE AT THE TIP OF THE INSTRUMENT. THE DEVICE WAS RETURNED BACK TO ISI FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306953 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 N/A 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES