BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15034066 · Received July 15, 2022

    Report

    Report Number
    2955842-2022-12986
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 17, 2022
    Report Date
    June 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR ARE UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS CANNOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THE SPECIFIC PROCEDURES/EVENT DATES ARE UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN A DRAFTED, UNPUBLISHED CLINICAL ARTICLE, IT IS NOTED THAT PERIOPERATIVE TRANSFUSION WAS NECESSARY IN 15 CHILDREN, MOSTLY ONCOLOGY CASES (N=12), IN ASSOCIATION WITH PATIENTS WHO HAD UNDERGONE UNSPECIFIED DA VINCI-ASSISTED XI SURGICAL PROCEDURES.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A DRAFTED, UNPUBLISHED CLINICAL ARTICLE. WITHIN THE DRAFTED CLINICAL ARTICLE, THE FOLLOWING IS NOTED: ¿PERIOPERATIVE TRANSFUSION WAS NECESSARY IN 5% OF CHILDREN (N=15), MOSTLY ONCOLOGY CASES (N=12).¿ ON 28-JUN-2022, ISI OBTAINED ADDITIONAL INFORMATION ABOUT THE DRAFTED CLINICAL ARTICLE COMPLAINT FROM THE AUTHOR. ACCORDING TO THE AUTHOR, A PROFESSOR STATED THAT PATIENTS ARE FOLLOWED UP ONE YEAR AFTER THE OPERATION AND THERE WERE NO POST-OPERATIVE COMPLICATIONS DUE TO THE DA VINCI ROBOT. THE PROFESSOR EXPLAINED THAT THE COMPLICATIONS ARE SURGICAL OR PATHOLOGICAL. THE PATIENTS' DEMOGRAPHIC INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136781 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A 00886874110720

    Patients

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