BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 25096073 · Received May 6, 2026

    Report

    Report Number
    2955842-2026-23185
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    June 20, 2025
    Report Date
    April 14, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. IMAGES ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. CITATION: DE GROOT, E. C. M., NYIRJESY, S. C., FADEN, D. L., LIN, D. T., DESCHLER, D. G., FENG, A. L., & RICHMON, J. D. (2025). SALVAGE TRANSORAL ROBOTIC SURGERY WITH SUBMENTAL FLAP RECONSTRUCTION: FUNCTIONAL AND ONCOLOGIC OUTCOMES. ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY, 1¿9. HTTPS://DOI.ORG/10.1177/00034894251347103. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEAN AGE OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION A3A- PATIENT GENDER REPRESENTS THE MAJORITY OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION B7: THE PATIENT'S MEDICAL HISTORY IS UPDATED PER THE MAJORITY OF THE PATIENT'S CHARACTERISTICS IN THE ROBOTIC GROUP COHORT. SECTION D: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON BOTH DA VINCI SI OR SP SYSTEMS. THERE WAS NO DIFFERENTIATION PROVIDED REGARDING WHICH SYSTEM WAS USED PER PROCEDURE. 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 OF AN ARTICLE THAT EVALUATED THE PERIOPERATIVE, ONCOLOGIC, AND FUNCTIONAL OUTCOMES OF SALVAGE TRANSORAL ROBOTIC SURGERY (TORS) WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION FOR RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (OPSCC) WAS PERFORMED. THE RETROSPECTIVE STUDY ANALYZED 8 PATIENTS UNDERGOING SALVAGE TORS WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION BETWEEN DECEMBER 2019 AND FEBRUARY 2024. TWO PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS, INCLUDING NECK HEMATOMA REQUIRING INTERVENTION AND DEHYDRATION/FAILURE TO THRIVE REQUIRING READMISSION. TWO DEATHS WERE OBSERVED DURING LONG-TERM FOLLOW-UP (AT 4 MONTHS AND 27 MONTHS POSTOPERATIVELY), ACKNOWLEDGED BY THE AUTHORS AS PART OF OVERALL SURVIVAL OUTCOMES. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY ADVERSE EVENTS TO AN INTUITIVE SURGICAL, INC. (ISI) DEVICE. FOLLOW-UP WITH THE AUTHOR PROVIDED THE FOLLOWING INFORMATION: "THOSE WERE ANTICIPATED ONCOLOGIC OUTCOMES, INDEPENDENT OF THE ROBOT. THERE WERE NO MALFUNCTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418964 DA VINCI DA VINCI NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1