BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 10882020 · Received November 22, 2020

    Report

    Report Number
    2955842-2020-11234
    Event Type
    Death
    Date Received
    November 22, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 29-MAY-2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A PUBLISHED REPORT IN MAINICHI NEWSPAPERS. THE PATIENT EXPIRED DUE TO HYPOXIC ENCEPHALOPATHY ON (B)(6) 2020 (17 DAYS POSTOPERATIVELY). ON 06-JUN-2022 AN ISI INTERNAL MEDICAL SAFETY OFFICER PROVIDED THE FOLLOWING AFTER REVIEWING THE CASE INFORMATION: BASED UPON THE DESCRIPTION OF EVENTS, IT IS NOT CLEAR AS TO WHAT CAUSED THE ¿FORCEPS¿ TO ACCIDENTALLY INJURE TO THE PATIENT¿S PULMONARY ARTERY DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY THAT ULTIMATELY LED TO THE PATIENT¿S MORTALITY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REPORTED INTRA-OPERATIVE BLEEDING CANNOT BE DETERMINED. THE SITE WAS UNWILLING TO PROVIDE ANY INFORMATION REGARDING THE INTRA-OPERATIVE COMPLICATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. SYSTEM: ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. THERE WERE NO SYSTEM ERRORS FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. NONE OF THE INSTRUMENTS USED DURING THE PROCEDURE WERE USED IN SUBSEQUENT PROCEDURES. HOWEVER A SITE REVIEW CONFIRMED THERE ARE NO COMPLAINTS AGAINST THESE INSTRUMENTS. IMAGE/VIDEO REVIEW: NO IMAGES OR VIDEOS WERE SHARED FOR THE EVENT SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. THE SURGEON REPORTEDLY CONVERTED THE DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE TO OPEN SURGERY TO CONTROL THE BLEEDING. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE BLEEDING IS UNKNOWN. THERE IS NO ALLEGATION BY THE SITE OR THE SURGEON THAT AN ISI DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INTRA-OPERATIVE BLEEDING OR THAT AN ISI DEVICE MALFUNCTIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, THE SURGEON "ACCIDENTALLY DAMAGED" THE PULMONARY ARTERY WITH FORCEPS. THE PROCEDURE WAS CONVERTED TO AN OPEN THORACOTOMY, AND A SPECIALIST FROM AN ADJACENT NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER WAS BROUGHT IN. THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND ON "HEART-LUNG MACHINES." THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD TRANSFUSION ADMINISTERED TO THE PATIENT. ON 04-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT A "FORCEPS" WAS IN USE WHEN THE PULMONARY ARTERY WAS INJURED. THE NURSE ON SITE INFORMED THAT THE SURGEON "DAMAGED THE PULMONARY ARTERY AS HE COULD NOT SEE THE ARTERY." AS A RESULT, THERE WAS BLEEDING, AND THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE TO CONTROL THE BLEEDING. AFTER THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE, A SPECIALIST WAS BROUGHT IN FROM A NEARBY HOSPITAL. IT IS UNKNOWN AS TO HOW THE BLEEDING WAS CONTROLLED. THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND DIAGNOSED AS "BRAIN DEAD." IT WAS CONFIRMED THAT THE INSTRUMENTS WERE INSPECTED PRIOR TO USE. THERE IS NO ALLEGATION BY THE SITE OR THE SURGEON THAT AN ISI DEVICE'S MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR THAT AN ISI DEVICE MALFUNCTIONED. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347324 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI INSTRUMENTS AND ACCESSORIES