BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21537784 · Received March 6, 2025

    Report

    Report Number
    2955842-2025-02270
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    September 17, 2024
    Report Date
    February 7, 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
    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. 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. CITATION: DENA G. SHEHATA, CHRISTOPHER S. DIGESU, EDILIN LOPEZ, CAROLINA VIGNA, SUSAN MOFFATT-BRUCE, CAMERON T. STOCK, ELLIOT L. SERVAIS, AMMARA A. WATKINS, ROBOTIC-ASSISTED PLEURECTOMY IS A SAFE AND EFFECTIVE SURGICAL TREATMENT FOR SPONTANEOUS PNEUMOTHORAX, JOURNAL OF SURGICAL RESEARCH, VOLUME 302, 2024, HTTPS://DOI.ORG/10.1016/J.JSS.2024.07.096. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. STUDY DEMOGRAPHICS IN THE ROBOTIC GROUP INCLUDED PATIENTS WITH A MEDIAN AGE OF 41 YEARS, MAJORITY (80%) OF THE PATIENTS WERE MALES FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE, SINGLE-CENTER ANALYSIS THAT INCLUDED 36 PATIENTS UNDERGOING 36 ROBOTIC-ASSISTED PLEURECTOMY (RAP) FOR SPONTANEOUS PNEUMOTHORAX FROM 2017 TO 2023. ONE PATIENT EXPERIENCED A GRADE 3B COMPLICATION, REQUIRING A RETURN TO THE OPERATING ROOM FOR AN ACUTE HEMOTHORAX. ANOTHER PATIENT WAS READMITTED DUE TO PLEURAL EFFUSIONS RELATED TO HEART FAILURE. THERE WERE NO INSTANCES OF 30-D MORTALITY OR PNEUMOTHORAX RECURRENCE DURING THE FOLLOW-UP PERIOD. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE DESIGNATED AUTHOR OF THE ARTICLE. PER THE AUTHOR, THERE WERE NO DEVICE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535631 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES