BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 13441900 · Received February 3, 2022

    Report

    Report Number
    2955842-2022-10170
    Event Type
    Death
    Date Received
    February 3, 2022
    Report Date
    January 10, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE POST-OPERATIVE PATIENT DEATHS CANNOT BE DETERMINED OR IS UNKNOWN. IT IS UNCLEAR IF THE FIVE POST-OPERATIVE DEATHS WERE ASSOCIATED WITH PATIENTS WHO UNDERWENT RATS VERSUS THE TS APPROACH. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWS NO OTHER COMPLAINTS RELATED TO THE COMPLICATIONS REPORTED IN THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. NO PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS WAS NOT POSSIBLE AS THERE ARE CURRENTLY THREE KNOWN DA VINCI XI SYSTEMS PRESENT AT THE PROCEDURE SITE: SK4021, SK4669, AND SU1196 AND THE PROCEDURE DATES ASSOCIATED WITH THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. LOG REVIEW IS NOT POSSIBLE DUE TO A LACK OF SYSTEM AND INSTRUMENT DETAILS, EVENT/PROCEDURE DATES, AND CONFIRMATION OF SITE LOCATION. AN ISI MEDICAL SAFETY OFFICER (MSO) MEDICAL REVIEW HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: BASED UPON THE INFORMATION PRESENTED IN THE DESCRIPTION OF EVENTS, NO COMMENTS ARE ABLE TO BE PROVIDED AS TO THE POTENTIAL CAUSE OF THE PATIENT DEATHS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING: WITHIN THE JOURNAL OF CLINICAL MEDICINE ARTICLE TITLED, ¿ROBOTIC VS. TRANSSTERNAL THYMECTOMY: A SINGLE-CENTER EXPERIENCE OVER 10 YEARS,¿ IT IS NOTED THAT FIVE PATIENT DIED DURING FOLLOW-UP AND ONLY ONE OF THESE DEATHS WAS DUE TO TUMOR PROGRESSION. ALTHOUGH THERE IS NO ALLEGATION WITHIN THE ARTICLE THAT A MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSES OF THE POST-OPERATIVE DEATHS ARE UNKNOWN. IT IS UNCLEAR IF THE FIVE POST-OPERATIVE DEATHS WERE ASSOCIATED WITH PATIENTS WHO UNDERWENT RATS VERSUS THE TS APPROACH. REFER TO THE REPORT WITH PATIENT IDENTIFIER #(B)(6) FOR ADDITIONAL INFORMATION REGARDING THE POST-OPERATIVE COMPLICATIONS (I.E. CHYLOTHORAX, PERICARDIAL EFFUSION, AND URINARY RETENTION) ASSOCIATED WITH RATS NOTED WITHIN THE ARTICLE.

    Description of Event or Problem · 0

    ON 10-JAN-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF CLINICAL MEDICINE ARTICLE TITLED, ¿ROBOTIC VS. TRANSSTERNAL THYMECTOMY: A SINGLE-CENTER EXPERIENCE OVER 10 YEARS¿ (KOCHER, G.J., ET. AL. 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS WERE NOTED. IN THE ROBOTIC GROUP, FIVE PATIENTS HAD A POST-OPERATIVE COMPLICATION THAT INCLUDED CHYLOTHORAX, PERICARDIAL EFFUSION, AND URINARY RETENTION. THE RESECTION OF SURROUNDING STRUCTURES WAS PERFORMED FOR FIVE PATIENTS IN THE ROBOTIC ASSISTED THORACIC SURGERY (RATS) GROUP AND SEVEN PATIENTS IN THE TRANSTERNAL (TS) GROUP. IT WAS FURTHER NOTED: "AFTER A MEAN FOLLOW-UP OF 44 MONTHS (RANGE 1-108), N = 4 PATIENTS WITH THYMOMA SHOWED RECURRENCE, 3 WERE TREATED VIA A TRANSSTERNAL APPROACH, AND ONLY 1 WAS TREATED VIA A RATS APPROACH. IN THE GROUP WITH THYMIC CARCINOMA, 1 PATIENT SHOWED PLEURAL RECURRENCE AFTER 14 MONTHS AND WAS TREATED THROUGH A MINIMALLY INVASIVE RESECTION OF THE RECURRENCE SITES. FIVE PATIENTS DIED DURING FOLLOW-UP; ONLY -ONE OF THESE DEATHS WAS DUE TO TUMOR PROGRESSION." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174250 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES