BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 15479645 · Received September 24, 2022

    Report

    Report Number
    2955842-2022-14162
    Event Type
    Death
    Date Received
    September 24, 2022
    Report Date
    August 25, 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, ALTHOUGH THE CAUSE OF THE DEATH IS DUE TO SEPSIS FROM THE INCARCERATED HERNIA, THE CAUSE OF THE INCARCERATED HERNIA IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME DUE TO LACK OF EVENT DETAILS. THE SURGERY DATES ARE UNKNOWN. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE ADVERSE EVENT DESCRIBED IS NOT UNIQUE TO AN ISI PRODUCT OR PROCEDURE. THE LIMITED INFORMATION DESCRIBES AN INCARCERATED HERNIA THAT WENT ON TO PERFORATE, WHICH LED TO SEPSIS AND ULTIMATELY DEATH. THERE ARE MANY TYPES OF HERNIAS; SOME ARE CONGENITAL, SOME ARE ACQUIRED, AND SOME CAN OCCUR POST OPERATIVELY. THE LOCATION AND TYPE OF HERNIA IS KEY INFORMATION BUT IS NOT SPECIFIED. NOR IS THE PERIOD OF TIME BETWEEN THE INITIAL ROBOTIC PROCEDURE AND THE SECOND PRESENTATION WHEN THE HERNIA WAS DISCOVERED. THESE ARE IMPORTANT DETAILS IN UNDERSTANDING HOW THE HERNIA MAY HAVE OCCURRED AND IF IT WAS RELATED TO THE INITIAL ROBOTIC PROCEDURE. THEREFORE, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF ANY INTUITIVE PRODUCTS CONTRIBUTED TO THIS PATIENT¿S DEATH. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE PATIENT REPORTEDLY EXPERIENCED AN INCARCERATED HERNIA. AS A RESULT, THE UNDERWENT A SECOND SURGICAL PROCEDURE PERFORMED NON-ROBOTICALLY FOR REPAIR OF THE INCARCERATED HERNIA. THE PATIENT EXPIRED WITHIN 24 HOURS OF THE SECOND NON-ROBOTIC PROCEDURE DUE TO SEPSIS. ALTHOUGH THE SURGEON INDICATED THAT THE INCARCERATED HERNIA WAS UNRELATED TO THE ROBOT, THE CAUSE OF THE POST-OPERATIVE COMPLICATION RESULTING WITH SEPSIS AND THE PATIENT'S SUBSEQUENT DEMISE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE PATIENT DEVELOPED A LEAK, WAS ADMITTED, AND SUBSEQUENTLY PASSED AWAY. THE DATE OF THE ROBOTIC PROCEDURE IS UNKNOWN. THE PATIENT POST-OPERATIVELY UNDERWENT A SECOND SURGICAL PROCEDURE PERFORMED NON-ROBOTICALLY FOR WHAT WAS BELIEVED TO BE AN INCARCERATED HERNIA. AT THAT TIME, IT WAS IDENTIFIED THAT "SOMETHING LEAKING LED TO SEPSIS." THE ROBOTIC SURGEON WAS OUT OF TOWN, SO HIS PARTNER PERFORMED THE SECOND SURGICAL PROCEDURE NON-ROBOTICALLY. DUE TO SEPSIS, THE PATIENT EXPIRED WITHIN 24 HOURS OF THE SECOND SURGICAL PROCEDURE FOR THE INCARCERATED HERNIA REPAIR. THE SURGEON HAD STATED THAT THE INCARCERATED HERNIA THAT LED TO THE PATIENT'S DEMISE WAS UNRELATED TO THE ROBOT. INTUITIVE SURGICAL, INC. (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
    1969974 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 00886874110720

    Patients

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