BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI XI

    MDR report key: 22610806 · Received July 25, 2025

    Report

    Report Number
    2955842-2025-31444
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 1, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR, AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU FOR FAILURE ANALYSIS. THE REPORTED ERROR COULD NOT BE CONFIRMED OR REPLICATED DURING TESTING. A REVIEW OF THE ERROR LOGS REVEALED NO DATA INDICATING THAT A FAULT HAD OCCURRED IN THE FIELD. INITIAL VISUAL INSPECTION FOUND NO ABNORMALITIES RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM, WHERE IT OPERATED AS EXPECTED: IT ENERGIZED AND CAUTERIZED PROPERLY, AND ALL PORTS SUCCESSFULLY RECOGNIZED INSTRUMENTS. HOWEVER, DURING FURTHER TESTING, THE UNIT INTERMITTENTLY FAILED THE TECHNICAL SAFETY CHECK RELATED TO THE AUTO-STOP TEST. A SECOND VISUAL INSPECTION AGAIN REVEALED NO PHYSICAL ANOMALIES ASSOCIATED WITH THIS FAILURE A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: H2 AND H11. ADDITIONAL INFORMATION: THE MARK WAS IDENTIFIED AS A "WELT," POSSIBLY CAUSED BY THE REMOVAL OF A MESH STOCKING; HOWEVER, THE EXACT CAUSE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: H2, H11. ADDITIONAL INFORMATION: THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR FOR FAILURE ANALYSIS EVALUATION. PER THE OEM, ACCORDING TO THE TECHNICAL SAFETY CHECK, THE FUNCTIONALITY AND SAFETY OF THE IESU GENERATOR WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, IT WAS INITIALLY BELIEVED THAT THE PATIENT HAD SUSTAINED BURN MARKS ON THE BUTTOCKS. HOWEVER, FOLLOW-UP INFORMATION FROM THE CUSTOMER CLARIFIED THAT THE MARKS WERE NOT BURNS. NO FURTHER DETAILS WERE PROVIDED REGARDING THE NATURE OF THE MARKS OR WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED. THE GROUNDING PAD WAS INSPECTED PRIOR TO THE PROCEDURE AND FOUND TO BE FREE OF ABNORMALITIES; IT WAS PROPERLY PLACED ON THE PATIENT¿S LEFT THIGH. DURING THE PROCEDURE, THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS SET TO COAG 4 AND CUT 3. AFTER THE PROCEDURE, WHEN THE MARKS WERE OBSERVED, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED. THE TSE REVIEWED THE ERROR LOGS AND FOUND NO RELEVANT ISSUES.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174937 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-08 N/A 00886874115343

    Patients

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