BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17646888 · Received August 29, 2023

    Report

    Report Number
    2955842-2023-18074
    Event Type
    Injury
    Date Received
    August 29, 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 A DA VINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. 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 BEING SUBMITTED FOR THE POST-OPERATIVE COMPLICATIONS. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER #(B)(6) IS BEING SUBMITTED FOR A CASE REPORT OF RESPIRATORY FAILURE. IN ADDITION, MEDWATCH REPORT WITH PATIENT IDENTIFIER #(B)(6) IS BEING SUBMITTED FOR A CASE REPORT OF PNEUMONIA AND ATRIAL FIBRILLATION 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. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. FOR SECTION A2, THE MEAN AGE OF THE PATIENTS WAS 40.9 +/- 16.7 YEARS. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    DURING REVIEW OF A CLINICAL ARTICLE TITLED, ¿OUTCOMES AFTER ROBOTIC THYMECTOMY IN NONTHYMOMATOUS VERSUS THYMOMATOUS PATIENTS WITH ACETYLCHOLINE-RECEPTOR-ANTIBODY-ASSOCIATED MYASTHENIA GRAVIS¿ (MARCUSE, F., ET AL., 2023), THE FOLLOWING EVENTS WERE MENTIONED: A RETROSPECTIVE REVIEW WAS CONDUCTED OF PATIENTS WITH ACETYLCHOLINE-RECEPTOR-ANTIBODY-ASSOCIATED MYASTHENIA GRAVIS (ACHR- MG) WHO UNDERWENT ROBOTIC THYMECTOMY (RATS) USING THE DA VINCI SYSTEM AT A SINGLE CENTER BETWEEN APRIL 2004 AND DECEMBER 2018. FOLLOW-UP DATA WAS COLLECTED FROM 60 REFERRING DUTCH HOSPITALS; 230 MYASTHENIC PATIENTS INCLUDING 76 PATIENTS WITH A THYMOMA WERE ENROLLED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS MENTIONED IN THE ARTICLE. THE PROCEDURE TIME WAS 106.4 (+/- 51.3) MINUTES FOR PATIENTS WITHOUT THYMOMA, AND 121.9 (+/- 54.2) MINUTES FOR PATIENTS WITH THYMOMA. PER THE ARTICLE, "WITHIN THE FIRST 30 DAYS AFTER THYMECTOMY, 20 COMPLICATIONS OCCURRED IN 15 PATIENTS." FIVE PATIENTS THAT HAD THYMOMA DEVELOPED ATRIAL FIBRILLATION, THREE PATIENTS HAD PLEURAL EFFUSION WITH DRAINAGE, TWO PATIENTS DEVELOPED PULMONARY EMBOLISM, TWO PATIENTS HAD PNEUMONIA, THREE PATIENTS HAD PNEUMOTHORAX THAT REQUIRED DRAINAGE, TWO PATIENTS HAD HEART FAILURE WHICH REQUIRED DIURETICS AND ONE PATIENT HAD RESPIRATORY FAILURE DUE TO SPUTUM. THERE WERE 8 COMPLICATIONS THAT OCCURRED DURING 30-120 DAYS AFTER RATS, WHICH INCLUDES PULMONARY EMBOLISM, CHYLOTHORAX, PHLEBITIS, PNEUMONIA, AND INCREASED IN MYASTHENIC SYMPTOMS. AT THE FOLLOW-UP PERIOD OF THE 165 PATIENTS WITH ACHR MYASTHENIA GRAVIS, 86 PATIENTS WITHOUT THYMOMA AND 50 PATIENTS WITH THYMOMA IMPROVED AFTER THYMECTOMY WITH NO MORTALITIES REPORTED. MULTIPLE ATTEMPTS HAVE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086131 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Unknown DA VINCI INSTRUMENTS AND ACCESSORIES