BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 9741818 · Received February 21, 2020

    Report

    Report Number
    2955842-2020-10133
    Event Type
    Death
    Date Received
    February 21, 2020
    Date of Event
    January 31, 2020
    Report Date
    January 31, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A2, A3, A4, A5, A6, D4, G4, G7 AND H2. ON(B)(6)2020 , INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS AN 81 YEAR OLD WHITE FEMALE BORN ON (B)(6)1946, WHO WEIGHED 81 KG. THE PATIENT'S REPORTED CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION/VENTRICULAR FIBRILLATION. THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED (B)(6)2020 .

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: A2 AND H10. FIELD A2, PATIENT AGE - SHOULD HAVE BEEN POPULATED AS 73 (PATIENT'S AGE AT THE DATE OF THE EVENT). FIELD H10 - THE PATIENT'S AGE PREVIOUSLY NOTED IN H10 AS 81 YEARS OLD SHOULD HAVE BEEN NOTED AS 73 YEARS OLD. ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: G4, G7, H2, H6, AND H10. 4310- A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: BASED UPON THE INFORMATION PROVIDED, THE DA VINCI SYSTEM AND INSTRUMENTATION DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH. THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION TOWARD THE END OF THE PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE PATIENT¿S MYOCARDIAL INFARCTION, SUCH AS ACUTE BLOOD LOSS ANEMIA. RELEVANT TO THE CASE WAS THE EMERGENT NATURE OF THE PROCEDURE. EMERGENT MAJOR OPERATIONS CARRY A HIGHER CARDIAC RISK WHEN COMPARED TO ELECTIVE MAJOR OPERATIONS. ADDITIONALLY, FACTORS THAT MAY CONTRIBUTE TO PERIOPERATIVE MYOCARDIAL ISCHEMIA ARE AS FOLLOWS: HYPOXEMIA DUE TO CHANGES IN PULMONARY FUNCTION AND/OR WEANING FROM THE VENTILATOR, REDUCED BLOOD PRESSURE FROM LEFT VENTRICULAR DYSFUNCTION, CORONARY VASOSPASM, INCREASED MYOCARDIAL WALL STRESS FROM HYPERVOLEMIA OR A RISE IN BLOOD PRESSURE, ARRHYTHMIAS DUE TO ELEVATION IN PLASMA CATECHOLAMINES, WITHDRAWAL OF BETA BLOCKERS OR PAIN, OR CHANGES IN BODY TEMPERATURE. THE SURGEON APPROPRIATELY STOPPED THE PROCEDURE ONCE THE PATIENT EXPERIENCED A PERIOPERATIVE MYOCARDIAL INFARCTION TO RESUSCITATE THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSES OF THE PATIENT¿S POST-OPERATIVE DEATH. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE THE PATIENT EXPERIENCED A HEART ATTACK. TWO DAYS AFTER THE PROCEDURE, THE PATIENT SUBSEQUENTLY EXPIRED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE THE PATIENT EXPERIENCED A HEART ATTACK. TWO DAYS AFTER THE PROCEDURE, THE PATIENT SUBSEQUENTLY EXPIRED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED. ON 02/03/2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ON (B)(6) 2020, THE PATIENT UNDERWENT A SIGMOID COLECTOMY. TOWARDS THE TAIL END OF THE PROCEDURE WHEN THE SURGEON WAS GETTING READY TO DO A LEAK TEST, THE PATIENT EXPERIENCED A HEART ATTACK. THE PROCEDURE WAS STOPPED WITHOUT TAKING THE SPECIMEN OUT. THE PATIENT WAS RESUSCITATED AND WAS ADMITTED TO THE ICU. ON (B)(6) 2020, THE PATIENT UNDERWENT A SECOND NON-ROBOTIC PROCEDURE TO EXTRACT THE SPECIMEN THAT WAS NOT REMOVED DURING THE ROBOTIC PROCEDURE. ON (B)(6) 2020, THE PATIENT EXPIRED. THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY TO HAVE OCCURRED DURING THE ROBOTIC PROCEDURE. THERE IS NO VIDEO RECORDING OF THE ROBOTIC PROCEDURE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202218 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 DA Death DA VINCI INSTRUMENTS AND ACCESSORIES