BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 9881254 · Received March 25, 2020

    Report

    Report Number
    2955842-2020-10230
    Event Type
    Death
    Date Received
    March 25, 2020
    Date of Event
    September 9, 2019
    Report Date
    September 9, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    0886874110720
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A2, G4, G7, H2, AND H10.CORRECTED DATA CAN BE FOUND IN SECTIONS A2.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH IS UNKNOWN. ISI CONTACTED THE SITE TO GATHER ADDITIONAL PATIENT DETAILS. HOWEVER, THE SITE WAS UNWILLING TO PROVIDE INFORMATION REGARDING THE PATIENT¿S MEDICAL HISTORY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THE LOG REVIEW SUPPORTS THE CUSTOMER CLAIM THAT THERE WAS NO PRODUCT ISSUE DURING THE CASE. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES WITH THE EXCEPTION OF THE FOLLOWING: 4 GREEN STAPLER 30 RELOADS (PART #48630G-03) WHICH ARE SINGLE USE INSTRUMENT ACCESSORIES; 3 WHITE STAPLER 30 RELOADS (PART #48630W-03) WHICH ARE SINGLE USE INSTRUMENT ACCESSORIES; 2 GREEN STAPLER 45 RELOADS (PART #48445G-04) WHICH ARE SINGLE USE INSTRUMENT ACCESSORIES; 2 WHITE STAPLER 45 RELOADS (PART #48645W-04) WHICH ARE SINGLE USE INSTRUMENT ACCESSORIES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE SURGEON ADMINISTERED 1 PINT OF BLOOD TO THE PATIENT. AFTER DOING SO, THE PATIENT EXPERIENCED A ¿REACTION¿ AND SUBSEQUENTLY EXPIRED. ALTHOUGH THE ROBOTICS COORDINATOR INDICATED THAT THE PATIENT¿S ¿REACTION¿ AND SUBSEQUENT DEATH WERE RELATED TO A BLOOD TRANSFUSION AND WERE UNRELATED TO THE DA VINCI SURGICAL SYSTEM, THE CAUSE OF THE INTRA-OPERATIVE BLEED IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON CALLED FOR 1 PINT OF BLOOD. IT WAS ALLEGED THAT THE BLOOD CAUSED AN UNSPECIFIED REACTION AND AS A RESULT, THE PATIENT SIDE CART (PSC) WAS UNDOCKED FROM THE PATIENT. CHEST COMPRESSIONS WERE ADMINISTERED. HOWEVER, THE PATIENT ULTIMATELY EXPIRED. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES MANAGER (CSM) AND GATHERED THE FOLLOWING INFORMATION: DURING A DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY, THE SURGEON CALLED FOR ONE UNIT OF BLOOD, AT WHICH TIME, THE CSM LEFT THE ROOM. THE SURGEON CALLED FOR ONE UNIT OF BLOOD WHICH WAS ADMINISTERED TO THE PATIENT. PER A CONVERSATION BETWEEN THE CSM AND THE SITE¿S ROBOTICS¿ COORDINATOR, OPERATING ROOM (OR) STAFF UNDOCKED THE PATIENT AND BEGAN CHEST COMPRESSIONS. AFTER 1 HOUR OF CHEST COMPRESSIONS, THE PATIENT WAS DEEMED TO HAVE EXPIRED. THE CSM INDICATED THAT SHE DID NOT KNOW WHAT CAUSED THE NEED FOR ADDITIONAL BLOOD. THE CSM SPOKE WITH THE OR STAFF AND WAS INFORMED THAT THEY BELIEVED THE EXPIRATION TO BE DUE TO AN ISSUE WITH THE BLOOD TRANSFUSION. THE CSM INDICATED THAT THERE WAS NO ALLEGATION THAT AN INTUITIVE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED NEED FOR BLOOD OR PATIENT EXPIRATION. ON (B)(6) 2019, ISI CONTACTED THE ROBOTICS COORDINATOR AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE ROBOTICS COORDINATOR VERIFIED THAT THE "REACTION" EXPERIENCED BY THE PATIENT AND HIS/HER SUBSEQUENT DEATH WAS RELATED TO A BLOOD TRANSFUSION THAT WAS ADMINISTERED. IN REGARDS TO THE REPORTED EVENT, THE ROBOTICS COORDINATOR STATED, "IT HAD NOTHING TO DO WITH THE ROBOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343111 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-32 N/A 0886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| L| R DA VINCI INSTRUMENTS AND ACCESSORIES