BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 17647494 · Received August 29, 2023

    Report

    Report Number
    2955842-2023-18088
    Event Type
    Death
    Date Received
    August 29, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 2, 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
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THE PHYSICIAN STATED THE EVENT IS NOT A DEVICE RELATED ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO NON-CONFORMANCES WERE FOUND WITH ANY OF THE INSTRUMENTS OR SYSTEMS USED DURING THIS PROCEDURE. A REVIEW OF THE SYSTEM LOGS FOR THIS PROCEDURE SHOWED THAT MULTIPLE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM AFTER THIS REPORTED EVENT WITH NO SERVICE REQUESTS BEING CREATED. NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. A REVIEW OF THE DEVICE LOGS FOR THE INSTRUMENTS USED DURING THE REPORTED PROCEDURE SHOWED THAT THE ENDOSCOPE AND ALL OF THE MULTI-USE INSTRUMENTS USED IN THE PROCEDURE WERE USED IN SUBSEQUENT PROCEDURES. THE ONLY SINGLE-USE INSTRUMENT, A SUCTION IRRIGATOR, WAS NOT USED IN ANY SUBSEQUENT PROCEDURES AND IS PRESUMED TO HAVE BEEN DISCARDED. A SITE HISTORY REVIEW SHOWS NO COMPLAINTS FILED AGAINST ANY OF THE INSTRUMENTS OR THE ENDOSCOPE. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT BASED ON THE AVAILABLE INFORMATION, THE PATIENT IN THIS REPORT HAD A SUDDEN DEATH FOLLOWING AN UNEVENTFUL HERNIA REPAIR WHERE NO INTRAOPERATIVE COMPLICATIONS, ISSUES, OR ERRORS WERE NOTED EITHER WITH THE SURGERY ITSELF OR ANY INTUITIVE SURGICAL INSTRUMENTS OR EQUIPMENT. THE SEQUENCE OF EVENTS AND THE MANNER OF EXPIRATION ARE HIGHLY SUGGESTIVE OF A PULMONARY EMBOLUS. BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, NO INTUITIVE PRODUCT CONTRIBUTED TO THIS EVENT. SECTION B2: DATE OF DEATH IS ESTIMATED AS (B)(6) 2023, AS DEATH REPORTEDLY OCCURRED 1-2 DAYS POST-PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED TRANS-ABDOMINAL PREPERITONEAL (TAPP) INCISIONAL HERNIA REPAIR, INTRAPERITONEAL ONLAY MESH (IPOM) VENTRAL HERNIA REPAIR, AND UNILATERAL INGUINAL HERNIA REPAIR SURGICAL PROCEDURES, THE PATIENT EXPIRED ONE TO TWO DAYS POSTOPERATIVE. THE INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS PRESENT THE DAY OF THE PROCEDURE AND OBSERVED THAT NO INTRA-OPERATIVE COMPLICATIONS OR ERRORS WITHIN THE DA VINCI SYSTEM OCCURRED DURING THE PROCEDURE. AFTER DISCUSSION WITH THE SURGEON, THE CSR LEARNED THAT THE PATIENT HAD A SLIGHTLY ELEVATED HEART RATE, THEN USED THE RESTROOM AND EXPIRED. THE SURGEON LATER CONFIRMED THAT THE PATIENT WAS DOING WELL WHILE HOSPITALIZED AND HAD A SUDDEN DEATH FROM A PULMONARY EMBOLUS (PE) OR A CARDIAC EVENT. THE SURGEON DID NOT THINK THE EVENT WAS A ROBOT ISSUE. THE SURGEON DECLINED TO PROVIDE FURTHER INFORMATION. THE PATIENT¿S FAMILY DECLINED AN AUTOPSY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288130 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.