BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 14586856 · Received June 3, 2022

    Report

    Report Number
    2955842-2022-11986
    Event Type
    Death
    Date Received
    June 3, 2022
    Report Date
    May 4, 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
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED COMPLICATIONS CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SYSTEM LOG REVIEW CANNOT BE CONDUCTED DUE TO LACK OF SYSTEM AND PROCEDURE DETAILS. NO VIDEO OR IMAGES WERE PROVIDED FOR REVIEW A REVIEW OF THE EVENT INFORMATION HAS BEEN PERFORMED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING WAS NOTED: "BASED UPON THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENTS, THE CAUSE OF THE TWO PULMONARY INFECTIONS THAT LED TO THE MULTI-ORGAN FAILURE AND DEATH FOLLOWING ¿ROBOTIC-ASSISTED SALVAGE SURGERY FOR OROPHARYNGEAL CANCER (OPC)¿ IS UNKNOWN. THE EXTENT TO WHICH THE DA VINCI MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT IS UNKNOWN." THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IN THE JOURNAL ARTICLE TITLED, ¿A PROSPECTIVE LONGITUDINAL STUDY OF QUALITY OF LIFE IN ROBOTIC-ASSISTED SALVAGE SURGERY FOR OROPHARYNGEAL CANCER¿ IT WAS REPORTED THAT POST-OPERATIVE DEATHS OCCURRED. AT THIS TIME, THE CAUSES OF THE DEATHS IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE POST-OPERATIVE COMPLICATIONS NOTED WITHIN THE ARTICLE THAT ARE NOT ASSOCIATED WITH PATIENT DEATHS. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS WERE EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. FIELD IS BLANK BECAUSE THE EVEN DATE IS UNKNOWN. THE EXPIRATION DATE FOR SECTION IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELDS ARE NOT APPLICABLE. FIELD IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    ON 04-MAY-2022, INTUITIVE BECAME AWARE OF AN EUROPEAN JOURNAL OF SURGICAL ONCOLOGY ARTICLE TITLED, ¿A PROSPECTIVE LONGITUDINAL STUDY OF QUALITY OF LIFE IN ROBOTIC-ASSISTED SALVAGE SURGERY FOR OROPHARYNGEAL CANCER¿ (D¿ANDREA, G., BORDENAVE, L., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS AND DEATH INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. A CLINICAL JOURNAL ARTICLE CITED THAT AN ANALYSIS OF DATA WAS CONDUCTED IN AN OBSERVATIONAL COHORT STUDY OF QUALITY OF LIFE IN ROBOTIC-ASSISTED SALVAGE SURGERY FOR OROPHARYNGEAL CANCER (OPC). DURING THE STUDY PERIOD, 53 PATIENTS UNDERWENT ROBOTIC-ASSISTED SURGERY. THE MEAN AGE WAS 64.3 YEARS. BETWEEN SEPTEMBER 2015 AND JANUARY 2021, ALL PATIENTS WHO UNDERWENT ROBOTIC SURGERY USING THE DA VINCI XI SURGICAL SYSTEM FOR A HISTOLOGICALLY PROVEN OPC ARISING IN A PREVIOUSLY IRRADIATED SITE WERE INCLUDED IN THE STUDY. THE PROCEDURES WERE EITHER EXCLUSIVELY TRANSORAL ROBOTIC SURGERY, OR COMBINED CERVICAL TRANSORAL ROBOTIC SURGERY, ACCORDING TO THE SIZE OF THE TUMOR, THE DEPTH OF INFILTRATION, AND THE ANATOMICAL CONSTRAINTS (NOTABLY DEEP VASCULAR SAFETY). MEDIAN FOLLOW-UP WAS 674 DAYS. COMPLICATIONS WERE RATED ACCORDING TO THE CLAVIEN-DINDO CLASSIFICATION. THE MAIN POSTOPERATIVE COMPLICATIONS WERE PULMONARY INFECTIONS, FOR 17 PATIENTS (32%). A POSTOPERATIVE HEMORRHAGE OF THE LOCAL SITE OCCURRED IN TWO PATIENTS (3.8%) AND A NECK HEMATOMA IN FOUR PATIENTS (7.6%). TWO PATIENTS REQUIRED A POSTOPERATIVE TRACHEOSTOMY FOR ACUTE RESPIRATORY DISTRESS. TWO PATIENTS DIED OF POSTOPERATIVE MULTI ORGAN FAILURE FOLLOWING SEVERE PULMONARY INFECTIONS DESPITE A PROPHYLACTIC TRACHEOSTOMY. PER THE AUTHORS, SALVAGE ROBOTIC-ASSISTED SURGERY FOR OPC MAY BE PREFERRED FOR PATIENTS WITH TUMORS AMENABLE TO EITHER A TRANSORAL OR A COMBINED CERVICAL TRANSORAL ROBOTIC APPROACHES. INTUITIVE SURGICAL INC. (ISI) MADE THE REQUIRED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THERE WAS NO RESPONSE RECEIVED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017235 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A

    Patients

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