BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 12872526 · Received November 24, 2021

    Report

    Report Number
    2955842-2021-11600
    Event Type
    Death
    Date Received
    November 24, 2021
    Date of Event
    October 27, 2021
    Report Date
    October 27, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST AN ADVERSE EVENT AS PREVIOUSLY REPORTED DUE TO THE REPORT OF POSTOPERATIVE LEAK, WHICH COULD POTENTIALLY BE RELATED TO A PRODUCT PROBLEM. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELDS: B1, ANNEX E AND ANNEX F B1 UPDATED FROM "ADVERSE EVENT" TO "ADVERSE EVENT AND PRODUCT PROBLEM" ANNEX E UPDATED TO INCLUDE E0506 DUE TO THE REPORT OF ¿POST OPERATIVE LEAK¿ ANNEX F UPDATED TO INCLUDE F0801 DUE TO THE REPORT OF ¿HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU).¿

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN ISI MEDICAL SAFETY OFFICER REVIEWED THE COMPLAINT INFORMATION AND WAS UNABLE TO DETERMINE IF THE DA VINCI SYSTEM, INSTRUMENT AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE PATIENT¿S ESOPHAGEAL LEAK AND SUBSEQUENT MORTALITY. NO IMAGES OR VIDEOS OF THE REPORTED EVENT WERE OBTAINED. THE EXACT EVENT DATE OF THIS DA VINCI-ASSISTED ESOPHAGECTOMY IS UNKNOWN. AN INSTRUMENT LOG REVIEW FOUND TWO NON-TRANSTHORACIC-TRANSHIATAL ESOPHAGECTOMIES PERFORMED BY THE REPORTED SURGEON OF THIS EVENT WITHIN ONE MONTH OF THE WEEK OF THE REPORTED PATIENT DEATH DATE. A REVIEW OF THE SYSTEM LOGS FOR THE PROCEDURE DATES OF (B)(6) 2021 AND (B)(6) 2021 HAS BEEN PERFORMED BY AN ISI POST-MARKET SURVEILLANCE SPECIALIST AND THE FOLLOWING WAS OBSERVED: NO RELEVANT ERRORS WERE OBSERVED DURING THESE PROCEDURES. ADDITIONALLY, ALL INSTRUMENTS AND ENDOSCOPES USED DURING THESE PROCEDURES WERE REUSED IN SUBSEQUENT PROCEDURES EXCEPT FOR ONE MEDIUM-LARGE CLIP APPLIER INSTRUMENT (PART NUMBER: 470327-12 / LOT NUMBER: N10201019-0085 / 87 INSTRUMENT USES REMAINING). A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALS THAT THIS MEDIUM-LARGE CLIP APPLIER INSTRUMENT HAS NO COMPLAINTS REPORTED AGAINST IT AND IS THEREFORE NOT EXPECTED TO BE RETURNED. EACH OF THESE PROCEDURES USED ONE VESSEL SEALER EXTEND INSTRUMENT WHICH IS A SINGLE-USE INSTRUMENT AND THEREFORE WERE NOT REUSED IN SUBSEQUENT PROCEDURES. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY EXPERIENCED A LEAK FOLLOWING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE WHICH RESULTED WITH PROLONGED HOSPITALIZATION. THE PATIENT REPORTEDLY WAS NEVER DISCHARGED AND PASSED AWAY IN THE HOSPITAL A FEW WEEKS AFTER THE DA VINCI-ASSISTED PROCEDURE. THE CAUSE OF THE POST-OPERATIVE COMPLICATION AND SUBSEQUENT PATIENT DEATH IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT AFTER A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, THE PATIENT HAD AN UNSPECIFIED LEAK AND WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT REPORTEDLY EXPIRED A FEW WEEKS AFTER THE PROCEDURE WHILE STILL HOSPITALIZED. THE PATIENT WAS NEVER DISCHARGED AFTER THIS PROCEDURE. ON 05-NOV-2021, AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED REGARDING THIS EVENT: THE CSR SAID HE WAS INFORMED OF THIS EVENT VIA A PHYSICIAN'S ASSISTANT. THE PHYSICIAN'S ASSISTANT SAID THE PATIENT EXPERIENCED A POST-OPERATIVE LEAK AND WAS TRANSFERRED TO THE ICU AND EXPIRED IN THE ICU. THE PATIENT DEATH DATE IS UNKNOWN BUT IT REPORTEDLY OCCURRED THE WEEK OF (B)(6). INTUITIVE SURGICAL, INC. (ISI) PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768087 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-20 UNKNOWN 00886874110720

    Patients

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