BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21109877 · Received January 9, 2025

    Report

    Report Number
    2955842-2025-00249
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 17, 2024
    Report Date
    December 17, 2024
    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
    TW
    Reporter Occupation
    003

    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 GENERATOR WAS ANALYZED AND FOUND TO HAVE ERROR C-34. AS ADDITIONAL OBSERVATION BEZEL HAS CRACK TOP LEFT CORNER. C-34 ERROR OCCURRED ON START AND MONO COAG ACTIVATION. ERBE UNIT WAS PLACED ON A SYSTEM AND WAS RUN IN NORMAL MODE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 25913 - ERBE ERROR: C-34 - HIGH FREQUENCY (HF) VOLTAGE TOO LOW IN ON STATE. THE PROBABLE ROOT IS ATTRIBUTED TO THE LOW MEASUREMENT VALUE FOR HF VOLTAGE.

    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 ERROR C-34. SYSTEM TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERROR: 25913.

    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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE THAT THERE WAS AN INTERMITTENT C-34 ERBE ERROR. THE CUSTOMER POWER CYCLED THE ERBE AND RECONNECTED THE ENERGY CABLES, BUT THE ISSUE PERSISTED. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERROR C-34 (VOLTAGE TOO LOW IN ON STATE). THE ISSUE WAS ESCALATED TO INTUITIVE FIELD SERVICE. THE PROCEDURE WAS COMPLETED AS PLANNED, WITH NO REPORTS OF PATIENT INJURY. INTUITIVE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE SYSTEM SHOWED NO ERRORS WHEN INITIALLY POWERED ON FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352318 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A 00886874110898

    Patients

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