BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14861677 · Received June 29, 2022

    Report

    Report Number
    2955842-2022-12574
    Event Type
    Injury
    Date Received
    June 29, 2022
    Report Date
    November 26, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 IN RELATION TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME BECAUSE OF INSUFFICIENT PRODUCT INFORMATION. THE EVENT DATE AND PRODUCT INFORMATION ARE UNKNOWN. A SYSTEM LOG REVIEW CANNOT BE PERFORMED AT THIS TIME BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. THE EVENT DATE IS UNKNOWN. NO IMAGE OR VIDEO WAS PROVIDED. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED AFTER UNDERGOING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE WITH INDOCYANINE GREEN-GUIDED EXTENDED PELVIC LYMPH NODE DISSECTION, THE PATIENT REQUIRED BLADDER REPAIR. THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION IS UNKNOWN. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED FOR THE BLADDER REPAIR. THE PATIENT¿S CURRENT STATUS WAS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS 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 · 0

    ON 26-NOV-2020, INTUITIVE SURGICAL, INC (ISI) BECAME AWARE OF THE INTERNATIONAL JOURNAL OF UROLOGY ARTICLE TITLED, ¿IMPACT OF INDOCYANINE GREEN-GUIDED EXTENDED PELVIC LYMPH NODE DISSECTION DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY¿ (S. SHIMBO, ET AL. 2020). WITHIN THE ARTICLE IT IS NOTED THAT ¿100 INDOCYANINE GREEN-GUIDED EXTENDED PELVIC LYMPH NODE DISSECTIONS IN PATIENTS WITH LOCALIZED INTERMEDIATE- AND HIGH-RISK PROSTATE CANCER, USING THE FIREFLY (NOVADAQ TECHNOLOGIES, MISSISSAUGA, ON, CANADA) AND DA VINCI XI SURGICAL SYSTEM¿ WERE CARRIED OUT BETWEEN JULY 2017 AND DECEMBER 2018. ALTHOUGH THE ARTICLE STATES THE FOLLOWING: ¿THERE WERE NO ADVERSE EVENTS SUCH AS EARLY OR LATE ALLERGIC REACTIONS, OR LOCAL BLEEDING FROM THE ICG INJECTION,¿ IT WAS NOTED THAT ¿ONE PATIENT REQUIRED BLADDER REPAIR. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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
    957467 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A

    Patients

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