BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17097931 · Received June 9, 2023

    Report

    Report Number
    2955842-2023-16127
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    May 15, 2023
    Report Date
    May 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO POWER SHORTAGE AND NOT DUE TO ANY SYSTEM, INSTRUMENT, OR ACCESSORY ISSUE. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SPOKE TO ISI CLINICAL SALES REPRESENTATIVE (CSR) ABOUT THE ISSUE. THE CSR AND THE CUSTOMER UNDERSTOOD THAT THE SYSTEM SHOULD NOT BE PLUGGED INTO A POWER STRIP, BUT RATHER IT IS RECOMMENDED TO HAVE EACH COMPONENT PLUGGED INTO A SEPARATE WALL OUTLET. THE CUSTOMER UNDERSTOOD MOVING FORWARD THAT PLUGGING INTO A WALL OUTLET AND RESTARTING SYSTEM WOULD HAVE BEEN THE SOLUTION TO THIS ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED.

    Description of Event or Problem · 0

    AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED THAT THE SYSTEM POWER SHUTDOWN IN THE MIDDLE OF THE CASE. THE CUSTOMER WAS CONFERENCED IN AND STATED THAT THEY SURGE PROTECTOR TRIPPED AND THE SYSTEM SHUTDOWN. THE CUSTOMER STATED THE SURGEON OPTED TO COVERT TO OPEN PRIOR TO CALLING IN. THE ISI TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THAT EACH UNIT PLUS THE ELECTROSURGICAL GENERATOR UNIT (ESU) SHOULD ALL HAVE THEIR OWN DEDICATED OUTLETS TO AVOID SUCH ISSUES. THE CUSTOMER ACKNOWLEDGED. THE CSR ACKNOWLEDGED AND STATED THAT THEY WOULD CHECK ON NEXT VISIT. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE CSR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS NOT CONVERTED DUE TO AN INTRA-OPERATIVE COMPLICATION. THE PATIENT TOLERATED THE CHANGE WELL. THEY CONVERTED DUE TO POWER SHORTAGE. THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228381 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N /A 00886874110898

    Patients

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