BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 16820537 · Received April 26, 2023

    Report

    Report Number
    2955842-2023-12222
    Event Type
    Death
    Date Received
    April 26, 2023
    Date of Event
    January 6, 2023
    Report Date
    April 7, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF DEATH IS UNKNOWN. NO PRODUCT HAS BEEN IMPLICATED OR RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. REVIEW OF THE PROCEDURE INSTRUMENT LOG FILES SHOW A SUREFORM 60 INSTRUMENT WAS INSTALLED ON THE SYSTEM 7 TIMES AND FIRED 6 RELOADS (6 WHITE). ON INSTALLATION 1, NO CLAMPING OR FIRING WAS ATTEMPTED. ON INSTALLATION 2, THE USER WAS PROMPTED TO SELECT THE WHITE RELOAD COLOR VIA THE GRAPHIC USER INTERFACE (GUI) ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD, DUE TO NOT FIRING ON THE PREVIOUS INSTALLATION. CLAMPING WAS SUCCESSFUL AND THE FIRING WAS COMPLETED WITH 3 PAUSES FOR COMPRESSION. ALL CLAMPS ATTEMPTED THROUGHOUT THE PROCEDURE WERE SUCCESSFUL. THERE WERE MULTIPLE PAUSES ON EACH FIRING. ON INSTALLATION 3, FIRING WAS COMPLETED WITH 3 PAUSES FOR COMPRESSION. ON INSTALLATION 4, FIRING WAS COMPLETED WITH 5 PAUSES. ON INSTALLATIONS 5-7, THE FIRINGS WERE COMPLETED WITH 1 PAUSE FOR COMPRESSION ON EACH. THERE WERE NO INCOMPLETE CLAMPS, INCOMPLETE UNCLAMPS, OR FIRING FAILURES FOR THIS INSTRUMENT. THERE WERE NO STAPLER RELATED ERRORS IN THE MASTER SUPERVISORY CONTROLLER (MSC) LOGS, HOWEVER, THERE WERE 5 ENGAGEMENT ERRORS RELATED TO THE MCS USED IN THE PROCEDURE PRESENT. A SYSTEM LOG REVIEW DETERMINED THAT THERE WERE NO SIGNIFICANT ISSUES OR ERRORS THAT OCCURRED DURING THE PROCEDURES. AT THE TIME OF REVIEW, THERE WERE 7 SUBSEQUENT PROCEDURES PERFORMED USING THE SYSTEM WITH NO REPORTED COMPLAINTS. DEVICE HISTORY RECORD REVIEW FOR THE DEVICE(S) USED DURING THE PROCEDURE SHOWED NO NON-CONFORMANCES WERE IDENTIFIED. REVIEW OF THE EVENT BY THE ISI MEDICAL SAFETY OFFICER (MSO) DOCUMENTS THAT THE PATIENT IN THIS REPORT DIED FOLLOWING A BARIATRIC SURGERY PROCEDURE AND THE DATE AND TIMING OF THE DEATH IN RELATION TO THE ORIGINAL PROCEDURE ARE UNKNOWN. THE INFORMATION IN THE SUMMARY OF EVENTS SUGGESTS THIS MAY HAVE HAPPENED AS AN OUTPATIENT AS THE PATIENT MISSED AN OUTPATIENT CLINIC APPOINTMENT. THE CAUSE OF DEATH, DATE OF DEATH, AND ANY POTENTIAL RELATIONSHIP TO THE ORIGINAL PROCEDURE ARE UNKNOWN. BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION EXISTS TO DETERMINE IF ANY INTUITIVE SURGICAL SYSTEMS OR INSTRUMENTS CONTRIBUTED TO THIS CATASTROPHIC EVENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED PROCEDURE, THE PATIENT EXPIRED ON AN UNKNOWN POST-OPERATIVE DAY. ALTHOUGH A HOSPITAL CONTACT CONFIRMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS, THERE IS INSUFFICIENT INFORMATION AVAILABLE. THE PATIENT'S POST-DISCHARGE COURSE AND THE TIMEFRAME AND CAUSE OF DEATH ARE UNKNOWN. SECTION B2: DATE OF DEATH - THE PATIENT MISSED A (B)(6) 2023 FOLLOW-UP APPOINTMENT. APPROXIMATELY 4-6 WEEKS PRIOR TO INFORMATION PROVIDED ON (B)(6) 2023 (TIMEFRAME OF (B)(6) 2023), THE USER FACILITY BECAME AWARE OF THE PATIENT DEATH VIA UNSPECIFIED WORD OF MOUTH. SECTION B3: DATE OF EVENT - (B)(6) 2023 REPRESENTS THE SURGICAL PROCEDURE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED ROUX-EN-Y PROCEDURE ON (B)(6) 2023, THE PATIENT EXPIRED. THROUGH FOLLOW UP WITH THE CUSTOMER, THE INTUITIVE SURGICAL, INC. CLINICAL SALES REPRESENTATIVE (CSR) LEARNED THAT THE PATIENT MISSED A POST-OPERATIVE APPOINTMENT IN FEBRUARY, SOUGHT CARE AT ANOTHER HOSPITAL FOR AN UNKNOWN REASON, AND ON AN UNKNOWN DATE, THE PATIENT EXPIRED. A REPORT SOURCE FROM THE HOSPITAL EXECUTIVE OFFICE CONFIRMED WITH THE CSR THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS. MULTIPLE UNSUCCESSFUL FOLLOW-UP ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING THE NATURE OF THE VISIT TO THE OTHER HOSPITAL, AND THE DATE AND CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591555 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES