BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24448959 · Received February 25, 2026

    Report

    Report Number
    2955842-2026-10106
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 3, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 NOT CONFIRMED THROUGH SYSTEM LOGS; HOWEVER, LOG REVIEW IDENTIFIED ERROR M-1F. A VISUAL INSPECTION REVEALED A CRACKED/BROKEN BEZEL. SUBSEQUENT FUNCTIONAL TESTING CONFIRMED THAT THE UNIT POWERED ON NORMALLY AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ISSUE. ADDITIONALLY, REVIEW OF THE INTERNAL ERBE ERROR LOG SHOWED THE PRESENCE OF M-0B. THE ERBE UNIT WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON SYSTEM LOGS; HOWEVER, FAILURE ANALYSIS COULD NOT REPLICATE THE ISSUE. THE PROBABLE ROOT CAUSE OF THE CUSTOMER-REPORTED ISSUE COULD NOT BE DETERMINED BASED ON THE FAILURE ANALYSIS RESULTS, AS NO FUNCTIONAL ISSUES WERE IDENTIFIED WITH THE ERBE UNIT. HOWEVER, GROUND PAD ERRORS WERE OBSERVED IN THE SYSTEM LOGS ON OTHER DAYS OF THE MONTH. THE ISSUE MAY BE RESOLVED BY VERIFYING THE GROUND PAD CONNECTION ON THE ERBE UNIT OR BY REPLACING THE ERBE UNIT.

    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO GROUND PAD ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE ERBE TO THE CUSTOMER REPORTED ISSUE. 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 USING AN XI SYSTEM, THE CUSTOMER CALLED TO REPORT THAT THE GROUNDING PAD ISSUE HAD RECURRED. THE CUSTOMER STATED THAT THE GROUNDING PAD FUNCTIONED ON THEIR ARM BUT DID NOT WORK ON THE PATIENT. THE CUSTOMER INDICATED THAT THEY HAVE TESTED SIX GROUNDING PADS WITH NO SUCCESS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED MOISTENING THE NEUTRAL PAD SITE WITH SALINE, WIPING IT ALMOST DRY, AND THEN REAPPLYING THE PAD. THE CUSTOMER AGREED TO ATTEMPT THIS APPROACH AND ENDED THE CALL. AT THIS TIME, IT IS UNKNOWN WHETHER THE PROCEDURE WAS COMPLETED USING THE ORIGINAL CONFIGURATION. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376273 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-44 N/A 00886874110898

    Patients

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