BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18758328 · Received February 22, 2024

    Report

    Report Number
    2955842-2024-11668
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    January 23, 2024
    Report Date
    January 23, 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
    SP
    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. DURING FIELD EVALUATION, FSE CONFIRMED A DEFECTIVE ERBE. AFTER REPLACEMENT, THE DA VINCI SYSTEM WAS RECALIBRATED, TESTED, OPERATED WITHOUT ERROR AND VERIFIED READY 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. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    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/ERBE) WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE IESU HAD NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL WAS NOT CRACKED. THE IESU WAS IN GOOD CONDITION.

    Additional Manufacturer Narrative · 0

    THE ERBE WAS SENT TO AND EVALUATED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). INITIAL FAILURE ANALYSIS (FA) FINDINGS WERE CONFIRMED AND REPRODUCED. THE UNIT GENERATED A C-34 ERROR ON START-UP. TROUBLESHOOTING LED TO A MALFUNCTIONING HF GENERATOR PCB TO BE THE CAUSE OF THE FAILURE AND ONCE REPLACED, THE ERROR CEASED. UNRELATED TO THE REPORTED ISSUE, THE SYSTEM CHECK MASTER PCB WAS ALSO REPLACED. THE UNIT IS FUNCTIONING AS INTENDED AFTER PASSING ALL THE REQUIRED AND RECOMMENDED TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE ERBE GENERATOR DISPLAYED ERROR CODE C-00 AND C-34 WHEN ATTEMPTING TO FIRE THE MONOPOLAR ENERGY (MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT). THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). PRIOR TO CALLING TSE, THE CUSTOMER REPLACED THE MONOPOLAR INSTRUMENT CABLE, THE INSTRUMENT, RESTARTED THE ERBE, AND TRIED THE SECOND MONOPOLAR PORT; HOWEVER, THE ISSUE PERSISTED. TSE CONFIRMED THAT THERE WAS NO DEVICE SUSCEPTIBLE TO PRODUCING ELECTROMAGNETIC INTERFERENCES SUCH AS A CT SCANNER OR OTHER GENERATORS. THE ERBE WAS DIRECTLY CONNECTED TO A DEDICATED AC PLUG. THE ERROR OCCURRED EACH TIME THE SURGEON TRIED TO FIRE THE MCS INSTRUMENT. THE CUSTOMER ALSO CONFIRMED THAT THE PEDALS IN THE DRAWER WERE NOT UNINTENTIONALLY PRESSED. TSE GUIDED THE CUSTOMER TO CHECK THE PROPER CONNECTION OF ALL THE CABLES IN THE BACK SIDE OF THE ERBE, ASKED TO POWER OFF THE ERBE, AND UNPLUGGED ITS POWER CORD FOR 30 SECONDS. THE CUSTOMER ELECTED TO DELAY PERFORMING THE TROUBLESHOOTING UNTIL AFTER THE PROCEDURE. AN EXTERNAL GENERATOR WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    59201 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

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