BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23395075 · Received October 27, 2025

    Report

    Report Number
    2955842-2025-41835
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 10, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS DUE TO THE COMMON COMPUTE CONTROLLER (CCC) CONVERTING TO A NON-CLINICAL IMAGE OF THE SOFTWARE. THIS ISSUE CAN BE RESOLVED BY HAVING THE FIELD SERVICE ENGINEER (FSE) REPROGRAM THE SYSTEM.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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 ERROR 311 AND GOLDEN IMAGE ISSUE WAS CONFIRMED. THE FSE REPROGRAMMED THE SYSTEM. THE FSE CONFIRMED THAT THE SYSTEM STARTED UP IN NORMAL MODE WITH NO FAULTS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    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 PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, THE SYSTEM SHUT DOWN. THE CUSTOMER RECEIVED THE MESSAGE SAYING, "COMMUNICATION ERROR DETECTED" AND TO "PRESS RESTART AND DA VINCI WILL TRY TO FIX THE ERROR." THE CUSTOMER PRESSED RESTART AND THE SYSTEM RESTARTED WITH AN ERROR 40096. THE SYSTEM LOGS WERE NOT UPLOADING. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH CONFIRMING ALL BLUE FIBER CABLES WERE FULLY SEATED AND THAT NO LOSS OF AC POWER OCCURRED. THE CUSTOMER THEN WAS IN THE PROCESS OF EMERGENCY UNDOCKING AND CONVERTING TO LAPAROSCOPIC SURGERY. THE SYSTEM LOGS WERE THEN AVAILABLE AND THE TSE OBSERVED AN ERROR 311 ON THE TOWER. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY. THE PATIENT TOLERATED THE CONVERSION. THERE WAS NO PATIENT INJURY. THE CUSTOMER UTILIZED THE SAME PORTS INTENDED FOR THE ROBOTIC CASE. THEY DID NOT ADD OR ENLARGE PORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352738 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES