BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 20886831 · Received December 9, 2024

    Report

    Report Number
    2955842-2024-22731
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    June 4, 2024
    Report Date
    November 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES OR THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. CITATION: KANG H, CHUNG H, LEE S, JANG T-K, SHIN S-J, KWON S-H, CHO C-H. COMPARISON OF LONG-TERM OUTCOMES IN EARLY-STAGE ENDOMETRIAL CANCER: ROBOTIC SINGLE-SITE VS. MULTIPORT LAPAROSCOPIC SURGERY. JOURNAL OF PERSONALIZED MEDICINE. 2024; 14(6):601. HTTPS://DOI.ORG/10.3390/JPM14060601 IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE.

    Description of Event or Problem · 0

    A RETROSPECTIVE, COHORT STUDY WHICH DESCRIBED A COMPARISON BETWEEN ROBOTIC SINGLE-SITE (RSS) AND MULTIPORT LAPAROSCOPIC (MPL) SURGERY, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE AIM OF THE STUDY WAS TO COMPARE RSS SURGERY TO MULTIPORT LAPAROSCOPIC SURGERY IN TERMS OF SURGICAL OUTCOMES AND OVERALL SURVIVAL FOR PATIENTS WITH EARLY ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM MARCH 2014 TO DECEMBER 2022 AND INCLUDED A TOTAL OF 421 PATIENTS OF WHICH 146 UNDERWENT RSS SURGERY WITH A MEDIAN AGE OF APPROXIMATELY 51.95 YEARS AND A MEDIAN BMI OF 24.82. ALL PATIENTS WERE FEMALE AS THE STUDY INVOLVED ENDOMETRIAL CANCER PATIENTS. THE ARTICLE NOTED THAT DURING THESE SURGERIES, PERIOPERATIVE COMPLICATIONS OCCURRED INCLUDING: ONE CASE OF AN INCISIONAL HERNIA, ONE CASE OF LYMPHOCELE, ONE CASE OF RECTUM TEAR, ONE OCCURRENCE OF VAGINAL CUFF BLEEDING, ONE CASE OF VAGINAL CUFF DISRUPTION, AND ONE CASE OF VAGINAL CUFF INFECTION. THERE WERE NO REPORTS OF ANY DA VINCI DEVICE MALFUNCTIONS NOR WERE THERE ANY ALLEGATIONS THAT ANY INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE DESIGNATED AUTHOR; HOWEVER, NO RESPONSE WAS RECEIVED. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634694 DA VINCI DA VINCI NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other DA VINCI INSTRUMENTS AND ACCESSORIES