BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16567155 · Received March 17, 2023

    Report

    Report Number
    2955842-2023-11358
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 24, 2023
    Report Date
    February 24, 2023
    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
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE E-100 WAS RED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT INTUITIVE SURGICAL, INC. (ISI) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE (ISI) WAS ABLE TO REPRODUCE THE ISSUE AS THE SYSTEM HAD A HARD FAULT ON STARTUP. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE E-100 WAS VISUALLY INSPECTED AND THEN INSTALLED IN A GOOD INTERNAL SYSTEM WHICH FAILED. THE POWER LED TURNED RED AND BIPOLAR LED WAS NOT TURNED ON WHICH COULD NOT CUT OR SEAL. THE COMPLAINT REGARDING THE E-100 TURNING RED WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER USED THE ERBE AFTER THE START OF THE PROCEDURE DUE TO A FAULTY E-100. THE FSE WENT ONSITE AND REPLACED THE E-100 GENERATOR DUE TO THE ERROR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA PARAESOPHAGEAL SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE E-100 WAS RED. THE CUSTOMER POWER CYCLED THE E-100 PRIOR TO CALLING IN AND HARD CYCLED THE E-100 WITH NO CHANGE. THE TECHNICAL SUPPORT ENGINEER (TSE) FOUND NO RELATED LOGS. THE TSE GUIDED THE CUSTOMER THROUGH AN E-100 RESET AND VERIFICATION OF CABLING HOWEVER THE ISSUE PERSISTED. THE SURGEON CONTINUED THE PROCEDURE WITH THE USE OF THE ERBE BIPOLAR. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. 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
    743055 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 N/A 00886874110898

    Patients

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