BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24825060 · Received April 9, 2026

    Report

    Report Number
    2955842-2026-20930
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 11, 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) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND THE ISSUE WAS CONFIRMED THROUGH SYSTEM LOG REVIEW, WHICH IDENTIFIED ERRORS M-10, M-32, AND M-36 ON 07-APR-2026, ALONG WITH M-12, M-11, M-18, AND C-06 RECORDED ON OTHER DAYS IN MARCH. 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.

    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. 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 INCISIONAL HERNIA IPOM SURGICAL PROCEDURE, THE TOWER PEDALS FOR THE PAST COUPLE OF DAYS. THE CALLER STATED THEY ARE GETTING AN ERROR WHILE USING THE PEDALS, M-10. 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 ERBE. TSE WAS NOT ABLE TO TROUBLESHOOT FURTHER SINCE NEEDED SETUP WAS NOT AVAILABLE. THE ERBE WAS GIVING THE ERROR AS SOON A SURGEON HIT THE PEDAL, USING MONOPOLAR CURVED SCISSOR. THE SITE CONFIRMED ERROR M-10, INSPECTED FOOT PEDALS WHICH WERE WORKING PROPERLY AND ACTIVATION IS BEING DETECTED BY ERBE. THE BOVIE WAS RULED OUT AND SURGEON KEEPING FOOT ON PEDAL AFTER AUTO STOP AS POSSIBLE ISSUE AND WILL ORDER AN ERBE TO REPLACE AND SEE IF ISSUE RESOLVES AFTER SWAP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94242 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-21 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1