BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI 5

    MDR report key: 20021097 · Received August 21, 2024

    Report

    Report Number
    2955842-2024-18416
    Event Type
    Death
    Date Received
    August 21, 2024
    Date of Event
    July 23, 2024
    Report Date
    July 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF ALL THE RELEVANT DOCUMENTATION, FOUND NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER SERVICE HISTORY REVIEW, THE DA VINCI SYSTEM, WITH THE EXCEPTION OF THE INSUFFLATOR THAT WAS REPLACED PER SITE REQUEST AND IS NOT AVAILABLE FOR EVALUATION, HAS BEEN IN USE WITHOUT ANY SUBSEQUENT COMPLAINTS RELATED TO THE REPORTED ADVERSE EVENT. THE EVENT OCCURRED DURING THE FIRST PORT PLACEMENT ATTEMPT. ONLY THE DAVINCI 5 INSUFFLATOR WAS USED; THE ROBOT WAS NEVER DOCKED TO THE PATIENT AS THE PORTS WERE NOT YET PLACED. REVIEW OF THE DA VINCI INSUFFLATOR DATA LOGS FOUND THAT THERE WERE 2 BRIEF PERIODS OF ACTIVE INSUFFLATION, THE FIRST LASTED APPROXIMATELY 34 SECONDS AND THE SECOND LASTED APPROXIMATELY 67 SECONDS. DURING BOTH ATTEMPTS, THE INSUFFLATION PRESSURES SHARPLY ROSE AND FLUCTUATED DURING EACH PERIOD. THE CO2 FLOW RATES ALSO VARIED DURING BOTH ATTEMPTS. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) TOGETHER WITH CLINICAL DEVELOPMENT ENGINEERS CONCLUDED THAT THE PATIENT IN THIS REPORT DIED SHORTLY AFTER THE START OF THE PROCEDURE WHEN AN ISSUE DEVELOPED DURING INSUFFLATION WHILE UTILIZING THE VERESS NEEDLE TECHNIQUE AT PALMER¿S POINT. ALTHOUGH THE SURGEON REPORTED A NORMAL SALINE DROP TEST, THE TIMING OF WHEN THIS DROP TEST WAS PERFORMED IS NOT PROVIDED. AS NOTED ABOVE, INSUFFLATOR DATA RECORDS TWO INSUFFLATION PERIODS. THE FIRST PLACEMENT DEMONSTRATED A HIGH PRESSURE IMMEDIATELY UPON ENTRY WHICH SUGGESTS AN INCORRECT VERESS NEEDLE PLACEMENT. THE SECOND PLACEMENT OF THE VERESS NEEDLE, APPROXIMATELY 25 SECONDS AFTER THE FIRST INSUFFLATION CEASED, BEGINS AT A SLIGHTLY HIGHER THAN TYPICAL INITIAL ABDOMINAL PRESSURE AND DOES NOT INCREASE IN A SLOW STEP WISE PROGRESSION AS TYPICALLY EXPECTED. THE PATIENT SUFFERED A CATASTROPHIC EVENT DURING THIS SECOND INSUFFLATION AND DIED. ALTHOUGH AN AUTOPSY WAS PERFORMED, THE CAUSE OF DEATH WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    THE SITE RISK MANAGER REPORTED THAT AN AUTOPSY IS PENDING IN QUEUE WITH AN UNKNOWN TIMELINE. AN INVESTIGATION IS ON-GOING AND RESULTS, INCLUDING THE INTUITIVE MEDICAL OFFICER REVIEW ARE PENDING ADDITIONAL INFORMATION. THE DA VINCI SYSTEM WAS NEVER DOCKED TO THE PATIENT; THEREFORE, SYSTEM AND INSTRUMENT LOGS ARE NOT AVAILABLE FOR REVIEW. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE DEVICE(S) USED DURING THE PROCEDURE AND NO NON-CONFORMANCE'S WERE IDENTIFIED TO BE RELATED TO THIS EVENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A VERESS NEEDLE FOR PORT PLACEMENT FOR A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, A PATIENT SUFFERED COMPLICATIONS THAT REQUIRED RESUSCITATION AND ULTIMATELY EXPIRED. THE PATIENT HAD URETERAL STENTS PLACED UNDER ANESTHESIA APPROXIMATELY 10-15 MINUTES BEFORE THE VERESS NEEDLE WAS PLACED WITH NO COMPLICATIONS. IT WAS REPORTED BY THE HOSPITAL RISK MANAGEMENT VERBALLY THAT THE OPERATIVE NOTES STATED THAT THE SURGEON WAS USING A VERESS NEEDLE AT PALMER'S POINT FOR THE FIRST PORT PLACEMENT WITHOUT ANY ISSUES. INSUFFLATION WAS INITIATED WITH THE DA VINCI INSUFFLATOR VIA THE VERESS NEEDLE AT LOW PRESSURE AND GRADUALLY INCREASED; THE SURGEON AND OR STAFF OBSERVED AN INCREASE IN THE PATIENT'S ABDOMEN WHILE INSUFFLATING. THE PATIENT WAS TOLERATING INSUFFLATION WELL UNTIL THE PRESSURE REACHED 15MMHG AT WHICH TIME THE PATIENT BECAME BRADYCARDIC AND THEN ASYSTOLIC. INSUFFLATION WAS STOPPED, CARDIOPULMONARY RESUSCITATION WAS INITIATED BUT WAS NOT SUCCESSFUL AND THE PATIENT EXPIRED. NO DA VINCI PORTS WERE PLACED AND THE DA VINCI SYSTEM WAS NEVER DOCKED; ONLY INSUFFLATION FROM THE VISION TOWER WAS USED. THE SITE RISK MANAGER, VP OF SURGERY AND CHIEF MEDICAL OFFICER STATED THEY DO NOT THINK THE COMPLICATION WAS CAUSED BY THE DA VINCI SYSTEM, INCLUDING THE INSUFFLATOR, AND THERE DOES NOT APPEAR TO BE A MALFUNCTION OF ANY DA VINCI PRODUCT; HOWEVER, THEY DO NOT KNOW WHAT HAPPENED TO CAUSE THE PATIENT COMPLICATIONS AND ARE AWAITING AUTOPSY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286414 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Death DA VINCI INSTRUMENTS AND ACCESSORIES