BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22111971 · Received May 30, 2025

    Report

    Report Number
    2955842-2025-23050
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 12, 2025
    Report Date
    May 12, 2025
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANNEX D WAS UPDATED TO D1501

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL INC., (ISI) DID RECEIVE THE ERBE INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIT WAS CONNECTED TO THE SYSTEM. THE UNIT DISPLAYED ERROR C-34 ON START-UP AND UPON ACTIVATING MONOPOLAR COAG. A REVIEW OF SYSTEM LOGS SHOWED THAT UNIT FAULTED WITH ERROR 25913 C-34 ON THE REPORTED EVENT DATE. VISUAL INSPECTION SHOWED THAT FRONT BEZEL WAS CRACKED FROM TOP LEFT CORNER. THE PROBABLE CAUSE OF ERROR C-34 IS ATTRIBUTED TO A FAULTY ELECTRICAL COMPONENT INSIDE THE ERBE GENERATOR. THIS ERROR INDICATES A LOWER VOLTAGE THAN EXPECTED DURING ENERGY ACTIVATION.

    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 INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE WAS FAULTING WITH ERROR C-34. AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED CUSTOMER TO PULL OUT UNIT'S POWER CORD. THE CUSTOMER WAS UNABLE TO DO SO DURING THE SURGERY. TSE INFORMED CUSTOMER THAT UNIT MIGHT NEED A SERVICE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. AN ISI FIELD SERVICE ENGINEER (FSE) TO FOLLOW-UP. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER CONFIRMED THE TIMING OF PROCEDURE. THE PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP THE ERBE. THE SYSTEM/UNIT POWERED ON WITHOUT ANY ERRORS. THE CUSTOMER CONNECTED A THIRD PARTY/COVIDIEN ELECTROSURGICAL UNIT (ESU) TO THE SYSTEM AND COMPLETED THE PROCEDURE WITH THE SAME THIRD-PARTY GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528977 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 00886874110898

    Patients

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