BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 24490047 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14643
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 3, 2026
    Report Date
    April 17, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G6, H2, H3, H6, H11. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENERGY SHIELD MONITOR (ESM) ASSOCIATED WITH THIS COMPLAINT FOR FAILURE ANALYSIS EVALUATION. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE GREEN MONOPOLAR CABLE WAS SHOWING INTERMITTENT CONNECTION ISSUES. ANYTIME THE CABLE WAS MOVED, THE CORD LIGHT WOULD FLASH AMBER. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS.

    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 ARRIVED ON-SITE AND REPLACED THE ENERGY SHIELD MONITOR (ESM). THE SYSTEM WAS TESTED AND VERIFIED READY FOR USE. THE ESM REPORTED IN THIS EVENT HAS NOT YET BEEN RECEIVED FOR FAILURE ANALYSIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT COLECTOMY PROCEDURE, THERE WAS INADEQUATE ENERGY TO STOP BLEEDING. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE AND CAUSE OF THE BLEEDING, THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE COMPLICATION, AND WHAT SURGICAL/MEDICAL INTERVENTION WAS RENDERED DUE TO THE BLEEDING. ADDITIONALLY, IT WAS REPORTED THAT AN UNSPECIFIED INSTRUMENT WAS EXPERIENCING ISSUES CONNECTING TO THE ENERGY SHIELD MONITOR (ESM) VIA THE GREEN MONOPOLAR CORD. THE CUSTOMER WAS REPORTEDLY LOSING CONNECTION VIA THE MONOPOLAR CORD AND GETTING A "BAD CORD" MESSAGE. FURTHERMORE, ENERGY WOULD START AND THEN STOP. MULTIPLE CORDS AND INSTRUMENTS WERE TRIED WITHOUT SUCCESSFULLY RESOLVING THE ISSUE. THE PROCEDURE WAS COMPLETED USING THE SAME GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235228 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-48 N/A 00886874114742

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other DA VINCI INSTRUMENTS AND ACCESSORIES.