BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24624542 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-15805
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    April 25, 2025
    Report Date
    February 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2022-14-C, ISIFA202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A LOG REVIEW COULD NOT BE CONDUCTED DUE TO INSUFFICIENT INFORMATION PROVIDED. THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. CITATION: UEDA, T., ET AL. (2025). EFFICACY OF VASCULAR LIGATION FOR THE PREVENTION OF INTRA- AND POSTOPERATIVE BLEEDING IN TRANSORAL ROBOTIC SURGERY FOR OROPHARYNGEAL CANCER. CANCERS, 17, 1446. HTTPS://DOI.ORG/10.3390/CANCERS1709144. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEDIAN AGE OF 71 YEARS (RANGE 30-81 YEARS) OF PATIENTS IN THE ROBOTIC GROUP. SECTION A3A: PATIENT GENDER IS SELECTED AS MALE. (82.9% OF THE PATIENTS IN THE ROBOTIC GROUP PATIENTS ARE MALE). SECTION B7: THE PATIENT'S MEDICAL HISTORY IS UPDATED PER THE MAJORITY OF THE PATIENT'S CHARACTERISTICS IN THE ROBOTIC GROUP COHORT. SECTION D: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. SECTION E: THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED AN APPROPRIATE SUBSTITUTION. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT.

    Description of Event or Problem · 0

    A REVIEW WAS PERFORMED OF AN ARTICLE THAT EVALUATED THE METHODS OF VASCULAR LIGATION AND NECK DISSECTION IN TRANSORAL ROBOTIC SURGERY FOR OROPHARYNGEAL CANCER IN JAPAN. THE STUDY ANALYZED 44 PATIENTS UNDERGOING TRANSORAL ROBOTIC SURGERY (TORS) BETWEEN DECEMBER 2019 AND DECEMBER 2023. ALL TORS PROCEDURES WERE PERFORMED USING THE DA VINCI XI SURGICAL SYSTEM. ONE PATIENT EXPERIENCED INTERMEDIATE-SEVERITY HEMORRHAGE AFTER DISCHARGE ON POST OPERATIVE DAY 14, REQUIRING A RETURN TO THE OPERATING ROOM FOR OPERATIVE CONTROL OF BLEEDING. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28670 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES