BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 22630183 · Received July 28, 2025

    Report

    Report Number
    2955842-2025-31450
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED PSM #2 TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PSM FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE PSM HAS NOT BEEN COMPLETED.

    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. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM). 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. IN THE SYSTEM LOGS, ERROR NODE NOT PRESENT AND CURRENT VOLTAGE MONITOR ERRORS WERE SEEN POINTING TO THE SURGICAL AXIS BRUSHLESS MOTOR CONTROLLER (SAC) NODE. MULTIPLE COMMUNICATION ERRORS WERE ALSO SEEN. DURING VISUAL INSPECTION, THE INSERTION FLAT FLEX CABLES WERE TORN AND THE PROXIMAL BELT WAS BROKEN. THE PSM WAS PARTIALLY DISASSEMBLED TO INSPECT THE NINE AXIS DRIVE (NAD) PCA AND A PIECE OF THE BELT WAS SEEN STUCK BETWEEN THE DISCRETE BRUSHLESS MOTOR AMPLIFIER (DBMA) PCAS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT A NON-RECOVERABLE FAULT OCCURRED. THE CUSTOMER POWER-CYCLED THE SYSTEM MULTIPLE TIMES; HOWEVER, THE ERROR RETURNED. THE CUSTOMER UNDOCKED AND POWER CYCLED THE SYSTEM AGAIN. THE ERROR RETURNED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO HARD POWER CYCLE THE SYSTEM AND PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC). THE SYSTEM POWERED UP AND AN ERROR AGAINST PATIENT SIDE MANIPULATOR (PSM) #2 WAS PRESENT. THE TSE HAD THE CALLER PERFORM A HARD POWER CYCLE AND PERFORM AN EPO AGAIN, KEEPING THE SYSTEM OFF LONGER. THE ERROR(S) RETURNED. THE TSE ADVISED TO CONTINUE TO PERFORM HARD CYCLES TO SEE IF THE ERROR WOULD CLEAR, AND ALSO ADVISED THAT THE ERRORS COULD RETURN. THE PROCEDURE WAS ULTIMATELY ABORTED AFTER ANESTHESIA HAD BEEN ADMINISTERED TO THE PATIENT AND PORTS HAD BEEN PLACED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575285 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-45 N/A 00886874114605

    Patients

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