BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23532938 · Received November 12, 2025

    Report

    Report Number
    2955842-2025-44832
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    December 20, 2024
    Report Date
    November 12, 2025
    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
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: LUNA, A., PEREZ-ROMERO, N., REBASA, P., ADELL, M., MONTMANY, S., CIDONCHA, A., HERRERO, C., & MORA, L. (2025). ROBOTIC GASTRECTOMY: CAN IT BE IMPLEMENTED WITHOUT COMPROMISING THE RESULTS? JOURNAL OF ROBOTIC SURGERY, 19(1). HTTPS://DOI.ORG/10.1007/S11701-024-02206-Z. CLINICAL ARTICLE PATIENT DEMOGRAPHIC INFORMATION: AGE MEDIAN (RANGE) 70.5 YEARS (48¿81). GENDER: FEMALE 21 (ROBOTIC), MALE 21 (ROBOTIC).

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE, "ROBOTIC GASTRECTOMY: CAN IT BE IMPLEMENTED WITHOUT COMPROMISING THE RESULTS?" WAS PERFORMED. THIS WAS A RETROSPECTIVE STUDY ON A PROSPECTIVE DATA REGISTRY INVOLVING PATIENTS WHO UNDERWENT RADICAL GASTRECTOMY (TOTAL OR DISTAL) FOR GASTRIC ADENOCARCINOMA UTILIZING THE DA VINCI XI AND X ROBOTIC PLATFORMS BETWEEN OCTOBER 2020 AND MARCH 2024. THE ARTICLE NOTED THAT DURING THE DA VINCI SURGERIES, INTRAOPERATIVE TRANSFUSIONS WERE REQUIRED IN 2 PATIENTS AND 1 PATIENT UNDERWENT A CONVERSION TO OPEN SURGERY. POSTOPERATIVE COMPLICATIONS OCCURRED IN 17 PATIENTS. SURGICAL REINTERVENTIONS WERE NECESSARY IN 5 CASES DUE TO SUTURE LEAKAGE, ACALCULOUS CHOLECYSTITIS (1), IATROGENIC GASTRIC PERFORATION (1), AND EVISCERATION (1). ALSO, 1 PATIENT WAS READMITTED WITHIN 30 DAYS DUE TO A POSTOPERATIVE COMPLICATION. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932306 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES