BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 23485243 · Received November 6, 2025

    Report

    Report Number
    2955842-2025-44138
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 10, 2025
    Report Date
    April 17, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: G3, G6, H2, H6, H11. CORRECTED FIELDS: H6, H11. ADDITIONAL INFORMATION: AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE OBSERVED NO OBSTACLES OR LIMITATIONS IN THE RANGE OF MOTION. THE FSE CLARIFIED THAT THE RANGE OF MOTION IS LIMITED BY DESIGN, AND NOTED THAT THE SURGEON IS ACCUSTOMED TO WORKING WITH THE GENERATION 4 SURGEON SIDE CONSOLE (SSC), WHEREAS THE DV5 CONSOLE IS APPROXIMATELY 10CM NARROWER COMPARED TO THE GEN 4 SSC. THE SYSTEM WAS TESTED AND CONFIRMED THAT THE SYSTEM FUNCTIONS AS DESIGNED AND READY FOR USE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. 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. A REVIEW OF THE IMAGES PROVIDED BY THE CUSTOMER REVEALS THAT ONE IMAGE DISPLAYS THE CURRENT ENERGY SETTINGS FOR BOTH MONOPOLAR AND BIPOLAR INSTRUMENTS ON THE ELECTROSURGICAL GENERATOR. THE SECOND IMAGE SHOWS THE DISTAL END OF A ROBOTIC CANNULA, WHICH APPEARS TO BE IN PROXIMITY TO AN ALLEGED BURN SITE ON THE ABDOMINAL BODY WALL. THERE IS A KNOWN RISK THAT ARCING CAN OCCUR WHEN USING MONOPOLAR INSTRUMENTS, ESPECIALLY AT HIGH WATTAGE LEVELS AND IN THE PRESENCE OF OTHER CONDUCTIVE MATERIALS. THIS RISK IS INHERENT TO ALL LAPAROSCOPIC SURGICAL PROCEDURES AND IS NOT UNIQUE TO DA VINCI SYSTEMS. WE DO WARN AGAINST CERTAIN INTRAOPERATIVE ACTIVITIES KNOWN TO INCREASE THE LIKELIHOOD OF ARCING IN THE DA VINCI INSTRUMENTS AND ACCESSORIES USER MANUAL. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR REPORT # 2955842-2025-44141 FOR MDR SUBMISSION OF THE ADVERSE EVENT/MALFUNCTION RELATED TO THE FUNCTIONALITY OF THE E200 GENERATOR. REFER TO MEDWATCH REPORT (MDR) WITH MFR REPORT # 2955842-2025-44140 FOR MDR SUBMISSION OF THE ADVERSE EVENT/MALFUNCTION RELATED TO A SPARK WAS OBSERVED ORIGINATING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND TRAVELING TO THE SUCTION IRRIGATOR, RESULTING IN A BURN INJURY TO THE PATIENT'S ABDOMINAL WALL.

    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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, A SPARK WAS OBSERVED ORIGINATING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND TRAVELING TO THE SUCTION IRRIGATOR, RESULTING IN A BURN INJURY TO THE PATIENT'S ABDOMINAL WALL. THE SEVERITY OF THE BURN AND WHETHER THE PATIENT REQUIRED ANY MEDICAL INTERVENTIONS REMAIN UNKNOWN. ACCORDING TO THE SURGEON, ISSUES RELATED TO HAND CONTROL SPACING AND THE FUNCTIONALITY OF THE E200 GENERATOR CONTRIBUTED TO THE COMPLICATION; HOWEVER, THE SPECIFIC PROBLEMS ENCOUNTERED BY THE SURGEON HAVE NOT BEEN DETAILED. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218557 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-50 N/A 00886874119747

    Patients

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