BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16870533 · Received May 4, 2023

    Report

    Report Number
    2955842-2023-12377
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 10, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO THE SYSTEM NOT GIVING THE OPTION TO USE THE TARGETING FEATURE. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND STATED THE TARGETING ISSUES WERE MOST LIKELY DUE TO USER ERROR. THE CSR FOLLOWED UP WITH THE HOSPITAL AND CONFIRMED THE ISSUE WAS USER ERROR AND THERE WAS NO NEED FOR SERVICE AT THIS TIME. NO SITE VISIT WAS CONDUCTED. FOLLOWING RESOLUTION, THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT THE CUSTOMER WAS UNABLE TO USE THE TARGETING FEATURE. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE INFORMED THE ISI FIELD SERVICE ENGINEER (FSE) THE ISSUE WAS USER ERROR AND THERE WAS NO NEED FOR SERVICE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHILE TROUBLESHOOTING FOR A DIFFERENT ISSUE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THEY HAVE CONVERTED THE PROCEDURE TO OPEN SURGERY. THE CUSTOMER MENTIONED THE SYSTEM WOULD NOT LET THE CUSTOMER TARGET DURING THE CASE AND THE SYSTEM DID NOT GIVE THE OPTION TO TARGET. IT IS UNCLEAR IF THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO ROBOT ISSUE. NO RELATED ERRORS IN THE LOGS. NO TROUBLESHOOTING PERFORMED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812338 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-30 N/A

    Patients

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