BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17283424 · Received July 7, 2023

    Report

    Report Number
    2955842-2023-16900
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 12, 2023
    Report Date
    June 12, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS FROM ORIGINAL EQUIPMENT MANUFACTURER: FAILURE ANALYSIS WAS UNABLE TO DUPLICATE C-00 ERROR. BIPOLAR FAILURE CONFIRMED ON BOTH SOCKETS, THE UNIT FAILED THE SHORT CIRCUIT FUNCTIONS TEST BY FAILING TO ALARM DURING THE INITIAL INVESTIGATION. AFTER THE CPU/SENSORIK PCB WAS REPLACED, FAILURE ANALYSIS WAS ABLE TO CALIBRATE THE UNIT WITHOUT ERROR. THE UNIT WAS FUNCTIONING AS INTENDED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BIPOLAR WAS NOT WORKING AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER VISITED THE SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE REPORTED ISSUE. ISI RECEIVED THE IESU; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE GENERATOR WAS ANALYZED, AND FAILURE ANALYSIS COULD NOT REPRODUCE THE REPORTED FAILURE. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE COMPLAINT REGARDING BIPOLAR NOT WORKING WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    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 BENIGN HYSTERECTOMY PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT BIPOLAR WAS NOT WORKING. THE CUSTOMER HAD REPLACED THE INSTRUMENT CORD AND THE FENESTRATED BIPOLAR INSTRUMENT, AND THE ISSUE PERSISTED. THEY DETERMINED THAT THE GENERATOR DOES MAKE A TONE WHEN THE SURGEON ACTIVATED THE BIPOLAR FOOT PEDAL; HOWEVER, THERE WAS NO ENERGY AT THE INSTRUMENT'S TIP. THE SURGEON WAS USING COAG 3 EFFECT LEVEL AND INCREASED IT TO 4 WITHOUT ANY CHANGE. THERE WERE NO ERRORS IN THE LOGS. THE CUSTOMER TRIED BOTH BIPOLAR PORTS AND A DIFFERENT ARM BUY THE ISSUE PERSISTED. THE TSE RECOMMENDED REPLACING THE CAUTERY CORD ONE MORE TIME AND POWER CYCLE THE INTEGRATED ELECTROSURGICAL UNIT (IESU), BUT THE ISSUE PERSISTED. THE SURGEON CONTINUED WITHOUT BIPOLAR. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND CONFIRMED THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE SAME IESU GENERATOR WITHOUT THE USE OF BIPOLAR ENERGY. THE INTUITIVE SERVICE LINE WAS CALLED, AND ALL STEPS WERE COMPLETED TO ATTEMPT TO RESOLVE THE ISSUE. THE SURGEON COMPLETED THE CASE ROBOTICALLY USING THE VESSEL SEALER WITH THE SEPARATE GENERATOR INSTEAD OF THE FENESTRATED BIPOLAR.

    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
    150662 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A

    Patients

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