BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 23764922 · Received December 10, 2025

    Report

    Report Number
    2955842-2025-47539
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 18, 2025
    Report Date
    February 11, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    ISIFA2024-09-C
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WAS ABLE TO REPRODUCE THE REPORTED CONDITION (ERROR 307) DURING A SYSTEM TEST DRIVE AND REPLACED THE LEFT MASTER TOOL MANIPULATOR (MTML) TO CORRECT THE PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MTML WAS ANALYZED AND A REVIEW OF DVSTREAM EVENTS SHOWED MULTIPLE ERRORS. DUE TO THE ERRORS, THE REPLACED UNIT WAS TRANSFERRED TO ENGINEERING FOR FURTHER REVIEW. FURTHER INVESTIGATIONS, REVEALED THE ROOT CAUSE IS DUE TO THE SLIP RING, SLIP RING CONSTRAINT, MANIPULATOR CONTROLLER MASTER PLATFORM (MCMP) BOARD AND MANIPULATOR CONTROLLER MASTER FOREARM (MCMF) BOARD. SECTION D SUSPECT MEDICAL DEVICE: CHANGED TO THE DA VINCI 5 SURGEON SIDE CART DUE TO FAILURE ANALYSIS INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A NEEDLE FELL OF A MEGA SUTURECUT NEEDLE DRIVER WHILE THE CUSTOMER WAS ATTEMPTING TO RESTART THE SYSTEM. THE NEEDLE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS NOT CONVERTED. THE PROCEDURE WAS COMPLETED ROBOTICALLY BY RESTARTING THE SYSTEM EACH TIME THE ERROR OCCURRED. AFTER THE NEEDLE FELL INTO THE PATIENT, AN X-RAY WAS PERFORMED TO LOCATE IT. THEY RETRIEVED THE NEEDLE WITH A LAPAROSCOPIC INSTRUMENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876129 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-46 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.