BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 23460899 · Received November 4, 2025

    Report

    Report Number
    2955842-2025-43772
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 24, 2025
    Report Date
    January 29, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED THE SINGLE-PORT ONE AXIS MANIPULATOR (SOAM) CONTROL BOARD B; HOWEVER, THE ISSUE PERSISTED. THE FSE REPLACED THE SMALL FORM-FACTOR PLUGGABLE (SFP) OF SOAM C WITH THE SFP OF SOAM B AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE SFP OF SOAM C IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE-PORT ONE AXIS MANIPULATOR (SOAM) CONTROL BOARD B TO PERFORM FAILURE ANALYSIS. THE SOAM B WAS ANALYZED. LOGS SHOW THE 319 ERROR WHICH INDICATES A NON-RECOVERABLE FAULT FROM SOAM C TO DOWNSTREAM CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION SOAM WAS MISSING A SMALL FORM-FACTOR PLUGGABLE (SFP), REPLICATING THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE SFP OF SOAM C IN THE PATIENT SIDE CART.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE SINGLE-PORT ONE AXIS MANIPULATOR CONTROLLER BOARD (SOAM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS REQUESTED THE SOAM TO BE RETURNED FOR FAILURE ANALYSIS TESTING. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD 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, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED A NON-RECOVERABLE FAULT 319 OCCURRED ON THE PATIENT SIDE CART (PSC). TROUBLESHOOTING BEGAN WITH A POWER CYCLE OF THE SYSTEM, BUT THE FAULT PERSISTED EVEN AFTER A HARD POWER CYCLE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC, AND EVENT LOGS WERE REVIEWED ONSITE. IT WAS FOUND THAT NON-RECOVERABLE FAULT 319 WAS REPORTED FROM SOAM C TO DOWNSTREAM. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO ADDITIONAL PORTS PLACED DUE TO THE CONVERSION TO TRADITIONAL LAPAROSCOPIC SURGERY. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686023 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-51 N/A 00886874114605

    Patients

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