BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16268243 · Received January 30, 2023

    Report

    Report Number
    2955842-2023-10394
    Event Type
    Injury
    Date Received
    January 30, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 4, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE ERBE FAULTED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SITE AND WAS ADVISED THAT THERE HAD BEEN NO FURTHER ISSUES. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THIS IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN AFTER THE START OF THE PROCEDURE DUE TO DISCOVERING THAT THE TUMOR WAS ATTACHED TO THE HEPATIC ARTERY AND DID NOT WISH TO USE THE DA VINCI SYSTEM TO ATTEMPT TO REMOVE IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THERE WAS A FAULT MESSAGE TWICE ON THE ERBE SCREEN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND A 2-8A ERROR. THE TSE HAD THE SITE'S CLINICAL SALES REPRESENTATIVE (CSR) CHECK THAT THE E-100 AND THE ERBE WEREN'T ON THE SAME OUTLET, WHICH THEY WEREN'T. THE TSE RECOMMENDED TO MAKE SURE THAT THE INSTRUMENT POWER CORDS FOR THE SYNCHROSEAL AND THE ERBE WERE SEPARATED FROM EACH OTHER. THE TSE ALSO ADVISED THAT THE SYNCHROSEAL ARCING COULD ALSO CAUSE THE ERROR. THE SITE CONVERTED TO OPEN FOR A REASON OTHER THAN SYSTEM. NO TROUBLESHOOTING STEPS WERE TAKING DURING THE CALL TO ENSURE THE ERROR WAS RESOLVED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO OPEN SOLELY BECAUSE THE TUMOR WAS STUCK TO THE HEPATIC ARTERY AND THE SURGEON DID NOT THINK THE PROCEDURE COULD BE COMPLETED WITH THE DA VINCI. THERE WERE ERROR MESSAGES AGAINST THE SYNCHROSEAL BUT THE INSTRUMENT WAS ABLE TO BE USED WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638637 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A

    Patients

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