BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21289360 · Received February 3, 2025

    Report

    Report Number
    2955842-2025-01061
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 13, 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
    MO, US
    Reporter Occupation
    003

    Narratives

    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. FSE REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (C-34/C-00 ERRORS) WAS CONFIRMED AND REPRODUCED ON GENERATOR CONNECTED TO SYSTEM. VISUAL INSPECTION SHOWED BEZEL WAS CRACKED TOP LEFT CORNER. THE COVER HAD A DEEP SCRATCH TO THE METAL ON SIDE. THERE WAS C-34 ERROR DURING START-UP AND MONO COAG ACTIVATION UNIT THAT WAS PLACED ON SYSTEM AND WAS RUN IN NORMAL MODE. THE ROOT CAUSE WAS ATTRIBUTED TO A HIGH FREQUENCY VOLTAGE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THERE WERE REPEATED ERRORS ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE CUSTOMER CLARIFIED THAT THEY OBSERVED ERROR C-34. THE TECHNICAL SERVICE ENGINEER (TSE) CONFIRMED ERROR C-34 ALONG WITH M-11, M-18, AND C-06. THE CUSTOMER ATTEMPTED TO USE BOTH MONOPOLAR ENERGY PORTS AND REBOOTED THE IESU MULTIPLE TIMES WITH NO RESOLUTION. THE CUSTOMER DID NOT HAVE AN AVAILABLE BACKUP GENERATOR AND OPTED TO CONTINUE THE CASE USING THE E-100 GENERATOR WITH A VESSEL SEALER INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088525 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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