BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 22881773 · Received August 25, 2025

    Report

    Report Number
    2955842-2025-35520
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 9, 2025
    Report Date
    August 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    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. CUSTOMER REPORTED THAT MONOPOLAR ENERGY COULD NOT BE ACTIVATED DURING THE PROCEDURE, WHILE BIPOLAR ENERGY FUNCTIONED NORMALLY. FOUR STATUS LEDS ON THE ENERGY SHIELD MONITOR (ESM) WERE BLUE. THE USER REPLACED THE MONOPOLAR CORD, BUT THE ISSUE PERSISTED. AFTER BEING INSTRUCTED TO POWER CYCLE THE SYSTEM, INSTALL A NEW NEUTRAL PAD, AND USE A NEW MONOPOLAR INSTRUMENT, THE PROBLEM REMAINED. IT WAS CONCLUDED THAT THE ESM WAS DEFECTIVE AND REQUIRED REPLACEMENT. THE SURGEON CONTINUED THE PROCEDURE USING A BIPOLAR INSTRUMENT AND REQUESTED FSE SUPPORT TO RESTORE MONOPOLAR ENERGY. FSE VISITED THE SITE AND OBSERVED THAT MONOPOLAR ENERGY COULD NOT BE ACTIVATED DUE TO INTERMITTENT ESM MALFUNCTION. THE ESM WAS REPLACED, AND THE REPLACEMENT WAS COMPLETED WITHOUT ISSUE. 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 ESM WAS ANALYZED AND FOUND VISUAL INSPECTION REVEALED NO ISSUES RELATED TO THE REPORTED EVENT. THE UNIT FUNCTIONED AS EXPECTED WHEN TESTED ON A GOLDEN SYSTEM, WITH ALL PORTS, CONNECTIONS, AND CAUTERY OPERATING NORMALLY. PARTIAL DISASSEMBLY AND INSPECTION OF THE CONFIGURATION PRINTED CIRCUIT ASSEMBLY (PCA) AND FACEPLATE SHOWED NO ABNORMALITIES. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IN THIS CASE CANNOT BE DETERMINED AS THE ISSUE WAS NOT CONFIRMED AND REPLICATED DURING THE FAILURE ANALYSIS. FSE HAVE REPLACED THE ESM DURING THE SITE VISIT TO RESOLVE THE CAUSED ISSUE.

    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 ENERGY SHIELD MONITOR (ESM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE ESM FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 SURGICAL TONGUE-BASED RESECTION PROCEDURE THAT THE MONOPOLAR ENERGY COULD NOT BE ACTIVATED. THE FOUR STATUS LEDS ON THE ENERGY SHIELD MONITOR (ESM) WERE BLUE. THE CUSTOMER REPLACED THE MONOPOLAR CORD, BUT THE ISSUE REMAINED. THE TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED TO POWER CYCLE THE SYSTEM, INSTALL A NEW GROUND PAD, AND REPLACE THE MONOPOLAR INSTRUMENT. THE SURGEON WAS STILL UNABLE TO ACTIVATE MONOPOLAR ENERGY. THE TSE ADVISED THAT A DEFECTIVE ESM CAUSED THIS ISSUE AND WOULD NEED TO BE REPLACED. THE SURGEON DECIDED TO CONTINUE THE PROCEDURE USING BIPOLAR ENERGY. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291870 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-51 N/A 00886874114742

    Patients

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