BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 15375569 · Received September 7, 2022

    Report

    Report Number
    2955842-2022-13893
    Event Type
    Death
    Date Received
    September 7, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 8, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION RESULTING WITH THE PATIENT'S DEMISE CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. A REVIEW OF THE EVENT INFORMATION WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO). PER THE MSO, MYOCARDIAL INFARCTION IS A KNOWN COMPLICATION FOLLOWING PULMONARY LOBECTOMY REGARDLESS OF THE TECHNIQUE OR EQUIPMENT USED. THIS PATIENT'S PAST MEDICAL HISTORY WITH KNOWN CORONARY DISEASE IS A SIGNIFICANT ADDITIONAL RISK FACTOR FOR THIS POST-OPERATIVE COMPLICATION. THE EVENT DETAILS PROVIDED SHOW NO INDICATION OF ANY SPECIFIC OR INFERRED MEDICAL DEVICE ISSUE THAT MAY HAVE CONTRIBUTED AS A FACTOR BUT MORE INFORMATION WOULD BE REQUIRED TO FULLY EXCLUDE SUCH A POSSIBILITY. AN ADVANCED INSTRUMENT LOG REVIEW FOR THE SUREFORM 60 STAPLER WAS PERFORMED FOR THIS PROCEDURE BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, THE LOGS SHOW SUREFORM 60 STAPLER INSTRUMENT (PART #480460-09, LOT #T93220127-0036) WAS INSTALLED 8 TIMES AND FIRED 8 RELOADS (2 GREEN, 1 BLUE, AND 5 GREEN IN THAT ORDER). ALL FIRINGS WERE COMPLETED PER THE LOGS WITH NO PAUSES, EXCEPT FOR THE 6TH FIRING, WHICH HAD 1 PAUSE FOR COMPRESSION. THERE WERE NO INCOMPLETE CLAMPS BY THIS INSTRUMENT. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT DIED. THE EVENT OCCURRED ON POD #7, AFTER THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION DURING HOSPITALIZATION. THE SITE DOES NOT KNOW IF THE PATIENT'S DEATH IS RELATED TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE CAUSE OF MYOCARDIAL INFARCTION LEADING TO THE PATIENT'S DEATH IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPIRED ON POST-OPERATIVE DAY (POD) #7. ON AN UNSPECIFIED DATE POST-OPERATIVELY AND WHILE THE PATIENT WAS STILL HOSPITALIZED, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. UNSPECIFIED MEDICAL INTERVENTION WAS RENDERED TO THE PATIENT; HOWEVER, THE PATIENT ULTIMATELY EXPIRED. THE SITE DOES NOT KNOW WHETHER THE DEATH OF THE PATIENT IS RELATED TO THE DA VINCI PROCEDURE; THEREFORE, THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. THERE WAS NO REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT¿S PRIOR SURGICAL HISTORY INCLUDED A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. THERE ARE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE PROCEDURE AVAILABLE FOR INTUITIVE SURGICAL, INC. (ISI) TO REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106544 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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