BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 12547746 · Received September 29, 2021

    Report

    Report Number
    2955842-2021-11219
    Event Type
    Injury
    Date Received
    September 29, 2021
    Report Date
    September 1, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE FOLLOWING INVESTIGATIONS COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED (I.E. EVENT DATE, SYSTEM SERIAL #, SURGEON NAME): SITE HISTORY REVIEW, EVENT VERIFICATION, SYSTEM/INSTRUMENT LOG REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PER A JOURNAL ARTICLE, THREE PATIENTS REPORTEDLY UNDERWENT DA VINCI-ASSISTED SURGICAL PROCEDURES AND EXPERIENCED CHYLOTHORAX AND A PROLONGED AIR LEAK WHICH REQUIRED THEM TO UNDERGO PLEURODESIS. ALTHOUGH THERE IS NO ALLEGATION OR EVIDENCE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSE OF THE OPERATIVE COMPLICATIONS IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 1

    ON 01-SEP-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A NAGOYA JOURNAL OF MEDICAL SCIENCE ARTICLE TITLED, ¿LEARNING CURVE OF ROBOTIC LOBECTOMY FOR LUNG MALIGNANCIES BY CERTIFIED THORACIC SURGEONS¿ (FUKUI, T., KAWAGUCHI, K., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: "THREE PATIENTS UNDERWENT PLEURODESIS FOR CHYLOTHORAX AND PROLONGED AIR LEAKAGE, BUT THERE WERE NO MORTALITY WITHIN 30 DAYS." 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
    1446892 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1