BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19921518 · Received August 6, 2024

    Report

    Report Number
    2955842-2024-17510
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 9, 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
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 (ERBE). SYSTEM TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE ERBE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED. THE IESU HAD NO SIGNIFICANT SCRATCHES OR DENTS AND THE FRONT BEZEL WAS NOT CRACKED. THE IESU WAS IN GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM REFLECTED AN ERROR C-34 MESSAGE ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. THE TECHNICAL SUPPORT ENGINEER (TSE) WENT THROUGH SEVERAL TROUBLESHOOTING STEPS; BUT THE ISSUE PERSISTED. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647897 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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