BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17622973 · Received August 25, 2023

    Report

    Report Number
    2955842-2023-18006
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    March 16, 2023
    Report Date
    July 31, 2023
    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
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENT CANNOT BE DETERMINED. THIS MEDWATCH REPORT (PATIENT IDENTIFIER # (B)(6)) IS SUBMITTED FOR A CASE REPORT OF PNEUMONIA AND ATRIAL FIBRILLATION, A MEDWATCH REPORT (PATIENT IDENTIFIER # (B)(6)) IS SUBMITTED FOR A CASE REPORT OF RESPIRATORY FAILURE AND THE MEDWATCH REPORT (PATIENT IDENTIFIER # (B)(6)) IS SUBMITTED FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE SAME ARTICLE. ARTICLE CITATION: MARCUSE F, HOEIJMAKERS JGJ, HOCHSTENBAG M, HAMID MA, KEIJZERS M, MANÉ-DAMAS M, MARTINEZ-MARTINEZ P, VERSCHUUREN J, KUKS J, BEEKMAN R, VAN DER KOOI AJ, VAN DOORN P, VAN ES M, MAESSEN JJG, DE BAETS MHV. OUTCOMES AFTER ROBOTIC THYMECTOMY IN NONTHYMOMATOUS VERSUS THYMOMATOUS PATIENTS WITH ACETYLCHOLINE-RECEPTOR-ANTIBODY-ASSOCIATED MYASTHENIA GRAVIS. NEUROMUSCUL DISORD. 2023 MAY;33(5):417-424. DOI: 10.1016/J.NMD.2023.03.005. EPUB 2023 MAR 16. PMID: 37037051.

    Description of Event or Problem · 0

    DURING REVIEW OF AN CLINICAL ARTICLE TITLED, ¿OUTCOMES AFTER ROBOTIC THYMECTOMY IN NONTHYMOMATOUS VERSUS THYMOMATOUS PATIENTS WITH ACETYLCHOLINE-RECEPTOR-ANTIBODY-ASSOCIATED MYASTHENIA GRAVIS¿ (MARCUSE, F., ET AL., 2023), A FOLLOWING CASE REPORT WAS MENTIONED. A PATIENT WHO WAS PREVIOUSLY TREATED WITH PREDNISONE AND AZATHIOPRINE UNDERWENT A DA VINCI ASSISTED THYMECTOMY FOR A THYMOMA. PRE-OPERATIVELY, THE PATIENT WAS ASSESSED AS MYASTHENIA GRAVIS FOUNDATION OF AMERICA (MGFA) MODERATE GENERALIZED WEAKNESS (MGFA CLASS III) AND PREDOMINANTLY INVOLVEMENT OF BULBAR/RESPIRATORY MUSCLES (CLASS B). THE PATIENT THEN HAD A COMPLICATED HOSPITALIZATION WITH A PNEUMONIA AND ATRIAL FIBRILLATION. ONE WEEK AFTER THE THYMECTOMY, THE PATIENT DEVELOPED MYASTHENIC CRISIS AND WAS INTUBATED. THE PATIENT RECOVERED AFTER TREATMENT WITH PLASMAPHERESIS AND PREDNISONE, AND INTRAVENOUS IMMUNOGLOBULIN. THERE WAS NO MENTION OF DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES MALFUNCTIONED DURING THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO ADDITIONAL INFORMATION HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077164 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.