BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21468842 · Received February 26, 2025

    Report

    Report Number
    2955842-2025-02203
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    July 22, 2024
    Report Date
    January 31, 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
    NY, 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: ARIAS-ESPINOSA, L., SALAS-PARRA, R., TAGERMAN, D. ET AL. ROBOTIC-ASSISTED ENDOSCOPIC ONLAY REPAIR (RENDOR) FOR CONCOMITANT VENTRAL HERNIAS AND DIASTASIS RECTI: INITIAL RESULTS AND SURGICAL TECHNIQUE. SURG ENDOSC 38, 5413¿5421 (2024). HTTPS://DOI.ORG/10.1007/S00464-024-11100-6 SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. THE MEDIAN AGE OF THE PATIENTS WAS 59 YEARS, AND THE MAJORITY (60 PERCENT) OF THE PATIENTS WERE FEMALES. 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 CASE SERIES STUDY THAT INCLUDED CONSECUTIVE 15 ADULT PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED ENDOSCOPIC ONLAY REPAIR (RENDOR) APPROACH FOR VENTRAL HERNIA REPAIR WITH DIASTASIS RECTI PLICATION FROM OCTOBER 2018 TO APRIL 2023, PERFORMED BY A SINGLE SURGEON. THE PROCEDURES WERE COMPLETED WITHOUT CONVERSIONS REPORTED. 12 (80 PERCENT) PATIENTS WERE DISCHARGED THE SAME DAY. POST-OPERATIVE COMPLICATIONS THAT WERE MENTIONED INCLUDED ONE PATIENT (6.6 PERCENT) FOR SURGICAL SITE INFECTION (SSI) REQUIRING INTRAVENOUS (IV) ANTIBIOTIC THERAPY AND RE-ADMISSION. THE ARTICLE AUTHOR CONFIRMED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS, NOR THAT ANY COMPLICATIONS WERE CONTRIBUTED TO OR CAUSED BY DA VINCI DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248877 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES.