BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 23566626 · Received November 17, 2025

    Report

    Report Number
    2955842-2025-45368
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 29, 2025
    Report Date
    April 3, 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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PATIENT SIDE MANIPULATOR (PSM) WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED EVENT WAS CONFIRMED BUT NOT REPLICATED. IN SYSTEM LOGS, ERROR 31009 WAS FOUND INDICATING FAILURE TO DETECT TOOL SENSORS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM AND FUNCTIONED AS EXPECTED. THE UNIT WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND PASSED ALL RELEVANT TESTING WITHIN SPECIFICATION. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. FAILURE ANALYSIS CONCLUDED THAT THE SPRING PLUNGER IS CONSISTENT WITH THE REPORTED EVENT AND IS A POTENTIAL ROOT CAUSE.

    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. FSE REPLACED TO PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE PSM.

    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 GENERAL HIATAL HERNIA PARAESOPHAGEAL SURGICAL PROCEDURE, INTUITIVE SURGICAL INC. REPRESENTATIVE REPORTED TO TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY WERE UNABLE TO TAKE THE INSTRUMENT OUT OF THE PATIENT SIDE MANIPULATOR (PSM2). THE CUSTOMER TRIED TO PRESS THE INSTRUMENT DISENGAGE BUTTON AND POWER CYCLING THE SYSTEM; HOWEVER, IT WAS UNSUCCESSFUL. TSE CHECKED ERROR LOGS WITH NO ERRORS OBSERVED. THE CUSTOMER CONFIRMED THE INSTRUMENT WAS HOLDING ONTO TISSUE, SO THEY WERE UNABLE TO RETRACT THE INSTRUMENT NOR TAKE OUT BOTH THE INSTRUMENT AND THE STERILE ADAPTER (SA) TOGETHER. THE CUSTOMER CALLED BACK AFTER THE PROCEDURE AND THE TSE GUIDED TO PRESS THE EMERGENCY STOP BUTTON AND WIGGLE THE INSTRUMENT AND SA IN AND OUT OF THE PSM, WITH NO IMPROVEMENT. THE CUSTOMER ALSO POWER CYCLED THE SYSTEM AND REPEATED THE ABOVE TROUBLESHOOTING; HOWEVER, IT WAS UNSUCCESSFUL. UPON FORCE MOVEMENT APPLIED, BOTH INSTRUMENT AND SA WERE PULLED OUT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DISENGAGE BUTTON WAS PRESSED PRIOR TO CONTINUING THE PROCEDURE. THE INSTRUMENT WAS REMOVED AFTER THE PROCEDURE WAS COMPLETED AND UNDOCKED FROM THE PATIENT THEREFORE THE INSTRUMENT WAS NOT HOLDING ONTO TISSUE WHEN THE EVENT OCCURRED. THE SYSTEM WAS IN PARKED POSITION AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362677 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-50 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1