BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 13518864 · Received February 11, 2022

    Report

    Report Number
    2955842-2022-10234
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    October 30, 2021
    Report Date
    January 18, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO ALLEGATION WITHIN THE JOURNAL ARTICLE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A SITE COMPLAINT HISTORY REVIEW WAS UNABLE TO BE CONDUCTED AT THIS TIME DUE TO LACK OF INSTRUMENT DETAIL AND LACK OF SPECIFIC EVENT/PROCEDURE DETAILS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM AND INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE CLINICAL ARTICLE TITLED, ¿POTENTIAL ADVANTAGES OF ROBOTIC TOTAL GASTRECTOMY FOR GASTRIC CANCER: A RETROSPECTIVE COMPARATIVE COHORT STUDY," IT IS NOTED THAT 15 PATIENTS EXPERIENCED GRADE A FISTULAS IN THE RTG GROUP. THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. IT IS ALSO UNKNOWN WAS MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE POST-OPERATIVE COMPLICATIONS. THERE IS NO ALLEGATION WITHIN THE JOURNAL ARTICLE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    ON 18-JAN-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿POTENTIAL ADVANTAGES OF ROBOTIC TOTAL GASTRECTOMY FOR GASTRIC CANCER: A RETROSPECTIVE COMPARATIVE COHORT STUDY¿ (KUMAMOTO, T., ISHIDA, Y., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: "GRADE A FISTULAS WERE OBSERVED IN 15 PATIENTS (57.7%) IN THE RTG (ROBOTIC TOTAL GASTRECTOMY) GROUP AND 18 PATIENTS (62.1%) IN THE LTG (LAPAROSCOPIC TOTAL GASTRECTOMY) GROUP (P = 0.603). AMONG PATIENTS WITH BMI = 25 KG/M2, GRADE A FISTULAS WERE OBSERVED IN 2 PATIENTS (33.3%) IN THE RTG GROUP AND 6 (75%) PATIENTS IN THE LTG GROUP (P = 0.277). AMONG PATIENTS WITH BMI < 25 KG/M2, GRADE A FISTULAS WERE OBSERVED IN 13 PATIENTS (65%) IN THE RTG GROUP AND 12 (57.1%) IN THE LTG GROUP (P = 0.751)." ISI HAS REACHED OUT TO THE AUTHOR TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS; HOWEVER, NO INFORMATION CAN BE OBTAINED AT THIS TIME DUE TO THE COVID-19 PANDEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111359 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 N/A

    Patients

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