BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 11330632 · Received February 15, 2021

    Report

    Report Number
    2955842-2021-10137
    Event Type
    Death
    Date Received
    February 15, 2021
    Date of Event
    December 31, 2020
    Report Date
    January 19, 2021
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF A PRODUCT ISSUE, HOWEVER THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SYSTEM LOG REVIEW WAS PERFORMED AND THERE WERE TWO PROCEDURES PERFORMED BY THE NOTED SURGEON AROUND THE TIMEFRAME REPORTED: (B)(6) 2020. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING EITHER SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE EVENT BY AN ISI INTERNAL MEDICAL SAFETY OFFICER HAS PROVIDED THE FOLLOWING INFORMATION AFTER REVIEWING THE CASE INFORMATION PROVIDED: THERE WAS NOT ENOUGH INFORMATION TO PROVIDE FURTHER ASSESSMENT OF THE EVENTS THAT OCCURRED DURING THE CASE. HOWEVER, THE ADVERSE EVENT DESCRIBED IS NOT UNIQUE TO AN ISI PRODUCT OR PROCEDURE. NO IMAGES OR PROCEDURE VIDEOS WERE SHARED FOR THE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME; HOWEVER, THERE WAS NO ALLEGATION THAT AN ISI DEVICE OR SYSTEM MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS DETERMINED TO BE PULMONARY FISTULA; AND, THERE WAS NO ALLEGATION OF AN INTUITIVE SURGICAL, INC. (ISI) DEVICE OR SYSTEM MALFUNCTION THAT HAD OCCURRED. IT WAS CONFIRMED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS THAT THE PATIENT HAD EXPERIENCED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. IT IS UNKNOWN AS TO WHEN THE PATIENT EXPERIENCED THE PULMONARY FISTULA. THE SURGEON BELIEVED THAT THE POSTOPERATIVE COMPLICATIONS WERE RELATED TO THE PATIENT'S MULTIPLE BASELINE CHARACTERISTICS; PULMONARY EMPHYSEMA, AND REDUCTION OF OPERABILITY DUE TO VERTEBRAL BODY SHAPE. IT IS UNKNOWN AS TO WHAT MEDICAL INTERVENTION WAS ADMINISTERED DUE TO POSTOPERATIVE COMPLICATIONS. THE DATE OF DEATH IS UNKNOWN. THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WAS MADE AWARE OF THE PATIENT'S DEATH AT THE END OF 2020. ALTHOUGH THE SURGEON BELIEVES THE CAUSE OF DEATH WAS A PULMONARY FISTULA, THE DETAILS OF THE DEATH CERTIFICATE OR AUTOPSY ARE UNKNOWN/NOT PROVIDED AT THIS TIME. THE SITE WILL NOT PROVIDE A VIDEO RECORDING OF THE PROCEDURE DUE TO PERSONAL INFORMATION. THE SURGEON'S COMMENTS ARE AS FOLLOWS: "THE PATIENT HAD AN EXISTING CONDITION OF PULMONARY EMPHYSEMA." MOREOVER, THE PATIENT HAD A GREATLY PROTRUDING VERTEBRA. THERE WERE INTRA-OPERATIVE PROBLEMS SUCH AS THE 3RD ARM PUTTING PRESSURE ON THE VERTEBRA IN THE INITIAL EXPOSURE WHEN PROCESSING THE SUPERIOR TRUNK. THE CAUSAL RELATIONSHIP WITH THIS PROBLEM IS UNKNOWN; HOWEVER, THE CAUSE OF DEATH WAS A PULMONARY FISTULA. ACCORDING TO THE SURGEON AND THE ASSISTANT, "THE PATIENT UNEXPECTEDLY HAD MANY BACKGROUND FACTORS THAT ACTED AGAINST A FAVORABLE OUTCOME. THEREFORE, THEY DO NOT BELIEVE THE ROBOT WAS THE DIRECT CAUSE." THE SITE CONFIRMED THAT NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223288 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES