BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24841161 · Received April 10, 2026

    Report

    Report Number
    2955842-2026-21233
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE WAS ANALYZED, AND THE ISSUE WAS CONFIRMED THROUGH SYSTEM LOG REVIEW, WHICH IDENTIFIED ERRORS M-10, M-32, M-36, M-12, M-11, M-18, AND C-06. A VISUAL INSPECTION INDICATED THAT THE UNIT WAS IN GOOD COSMETIC CONDITION. FUNCTIONAL TESTING SHOWED THAT THE UNIT POWERED ON NORMALLY AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ANY ISSUES. HOWEVER, INTERNAL ERBE LOG REVIEW REVEALED ERROR CODES M-0B, M-11, C-00, M-32, M-31, AND M-10. THE ERBE UNIT WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE CAUSE OF THE CUSTOMER-REPORTED ISSUE COULD NOT BE DETERMINED, AS FAILURE ANALYSIS IDENTIFIED NO FUNCTIONAL ISSUES WITH THE ERBE UNIT. HOWEVER, FOOT PEDAL ACTIVATION-RELATED ERRORS WERE OBSERVED IN THE ERBE SYSTEM LOGS. THIS ERROR INDICATES A FAULTY FOOT PEDAL OR SOME DEBRIS BEING CAUGHT UNDER THE FOOT PEDAL. THIS ERROR CAN BE RESOLVED THROUGH TROUBLESHOOTING OR REPLACEMENT OF THE GENERATOR. THE CAUSE CAN ALSO BE ATTRIBUTED TO AN ELECTRICAL COMPONENT PROBLEM WITHIN THE ERBE.

    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 WAS INFORMED THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE WAS TRIGGERING AN ERROR AS SOON AS THE SURGEON HIT THE PEDAL. FSE USED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND CONFIRMED ERROR M-10. FSE INSPECTED FOOT PEDALS WHICH WORKED PROPERLY, AND ACTIVATION WAS DETECTED BY THE ERBE. FSE RULED OUT BOVIE PEN AND SURGEON KEPT FOOT ON PEDAL AFTER AUTO STOP AS POSSIBLE ISSUES AND REPLACED THE ERBE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE ERBE FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    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 PROCEDURE, THE CUSTOMER REPORTED ISSUES WITH THE TOWER PEDALS FOR THE PAST COUPLE OF DAYS. THE CUSTOMER STATED THEY WERE GETTING AN ERROR M-10 WHILE USING THE PEDALS. TECH SUPPORT ENGINEER (TSE) DID NOT SEE ANY RELATED ERRORS FOR TODAY OR YESTERDAY. TSE INQUIRED HOW THE CUSTOMER WAS USING THE PEDALS, AND THEY STATED WITH A HANDHELD WITH NOTHING ELSE INSTALLED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. TSE WAS NOT ABLE TO TROUBLESHOOT FURTHER SINCE NEEDED SETUP WAS NOT AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429857 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-21 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1