BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18821948 · Received March 1, 2024

    Report

    Report Number
    2955842-2024-11973
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 8, 2024
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS ANALYZED, AND THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. ISI HAS NOT RECEIVED IESU FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ 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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE ERBE WAS GIVING AN ERROR C-34 WHEN ATTEMPTING TO FIRE THE MONOPOLAR ENERGY WITH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. BIPOLAR WAS WORKING. PRIOR TO CALLING THE TECH SUPPORT, THE CUSTOMER REPLACED THE MONOPOLAR INSTRUMENT CABLE, THE MCS INSTRUMENT, RESTARTED THE ERBE AND TRIED THE SECOND MONOPOLAR PORT; HOWEVER, THE REPORTED ISSUE PERSISTED. A TECHNICAL SERVICE ENGINEER (TSE) ASKED IF THERE WERE ANY DEVICE SUSCEPTIBLE TO PRODUCE ELECTROMAGNETIC INTERFERENCES SUCH AS CT SCAN OR OTHER GENERATORS, BUT IT WAS NOT THE CASE. THE GENERATOR WAS DIRECTLY CONNECTED TO A DEDICATED AC PLUG AND CABLES IN THE BACK SIDE OF THE GENERATOR SEEM TO BE PROPERLY CONNECTED. TSE INSTRUCTED TO POWER OFF THE GENERATOR AND UNPLUG ITS POWER CORD FOR 30 SECONDS. ALSO, TSE ASKED IF THEY HAD A FORCE TRIAD GENERATOR AND THE RELATED CABLE ALLOWING TO USE IT WITH THE SYSTEM. THE SURGEON PROCEEDED WITH THE SURGERY ONLY USING BIPOLAR AND THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212815 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A

    Patients

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