BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17466680 · Received August 4, 2023

    Report

    Report Number
    2955842-2023-17534
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 12, 2023
    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
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VIO INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS FURTHER ANALYZED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) AND IT WAS CONFIRMED THAT THE UNIT GENERATED M-12-6 ERROR ON START-UP. TROUBLESHOOTING LED TO A MALFUNCTION MONOPOLAR SOCKET #4. ONCE REPLACED, THE MENTIONED ERROR CEASED. UNRELATED TO THE REPORTED ISSUE INCLUDED THE TOP COVER HAS SCRATCHES.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR M-12 OCCURRED, 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. DURING FIELD EVALUATION, THE FSE CONDUCTED AN INSPECTION AND WAS ABLE TO REPRODUCE ERROR M-12. THE MONOPOLAR PORT 2 WAS NOT RECOGNIZED. THE FSE REPLACED THE IESU TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. DURING IN-HOUSE TESTING, THE IESU WAS ANALYZED, AND ERROR M-12-6 DISPLAYED REPEATEDLY WHEN RUNNING NORMAL MODE DURING BOOT UP. M-12-6/M-02/M-12 ERRORS ARE PRESENT IN ERROR LOG. THE COMPLAINT REGARDING ERROR M-12 WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    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 SURGICAL PROCEDURE, AN INTEGRATED ELECTROSURGICAL UNIT (IESU) ERROR M-12 APPEARED. THE CUSTOMER WAS NOT ABLE TO ACTIVATE THE LAPAROSCOPIC MONOPOLAR AND BIPOLAR INSTRUMENTS BY PRESSING THE IESU FOOT SWITCH WITH THE IESU. THIS ISSUE ONLY OCCURRED WITH THE LAPAROSCOPIC ENERGY INSTRUMENT WHILE THE DAVINCI INSTRUMENT HAD NO ISSUE. THE CUSTOMER USED AN EXTERNAL GENERATOR TO USE THE LAPAROSCOPIC ENERGY INSTRUMENT INSTEAD OF THE IESU. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON AND THE IESU INITIALIZED WITHOUT ERROR. THE IESU WAS FUNCTIONAL DURING THE PATIENT SIDE CART (PSC) DOCKED, BUT IT WAS NOT FUNCTIONAL DURING THE LAPAROSCOPE. THE SITE ELECTED TO ABANDON THE IESU. NO EXTRA PORT EXCISIONS WERE MADE. THE PATIENT HAD NO INJURY/HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811391 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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