BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19563973 · Received June 18, 2024

    Report

    Report Number
    2955842-2024-15555
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 21, 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
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS ANALYZED AND WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE (ERROR C-34 UPON MONOPOLAR COAGULATION ACTIVATION) WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    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 FIELD SERVICE ENGINEER (FSE) INSTALLED NEW INTEGRATED ELECTROSURGICAL UNIT (IESU) IN ACCORDANCE TO ISI PROCEDURES. THE SYSTEM IS TESTED AND VERIFIED FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE VISION SIDE SYSTEM (VSS) MONOPOLAR ENERGY ISN'T WORKING AND THEY'RE GETTING AND ERROR. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND REPEATED ERROR C-34. THE CUSTOMER HARD POWER CYCLED THE ERBE AND STILL HAVING ERRORS AND SWAPPED OUT THE INSTRUMENT AND ERROR PERSISTED. TSE HAD THE CUSTOMER HOOK UP A COVIDEAN VALLEY LAB BOVIE WITH THE ACTIVATION CABLE 371716 AND NOW THEY'RE ABLE TO PROCEED WITH THE CASE USING THE VALLEY LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578101 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES