BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21460255 · Received February 25, 2025

    Report

    Report Number
    2955842-2025-02047
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    August 20, 2024
    Report Date
    January 28, 2025
    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
    CH
    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: MUHAMMAD ALI, WEI WANG, LIUHUA WANG, BIN LIU, JUN REN, DAORONG WANG, GENDER DIFFERENCES IN ROBOTIC SURGERY FOR RECTAL CANCER: A RETROSPECTIVE STUDY, INTELLIGENT SURGERY, ISSN 2666-6766, HTTPS://DOI.ORG/10.1016/J.ISURG.2024.08.001. 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.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE STUDY THAT AIMED TO EVALUATE THE IMPACT OF GENDER ON THE OUTCOMES OF ROBOTIC SURGERY FOR RECTAL CANCER. THE STUDY INCLUDED 82 MALE AND 73 FEMALE PATIENTS THAT UNDERWENT ROBOTIC SURGERIES FOR RECTAL CANCER FROM JULY 2021 TO MARCH 2024. ACCORDING TO THE STUDY, MALE PATIENTS EXPERIENCED SHORTER HOSPITAL STAYS COMPARED TO FEMALES. OF THE 73 FEMALE PATIENTS, 4 PATIENTS EXPERIENCED SEPSIS, 6 PATIENTS EXPERIENCED ANASTOMOTIC FISTULA, 2 PATIENTS EXPERIENCED NECROSIS, THAT WERE CLASSIFIED AS CLAVIEN-DINDO GRADE III. THE STUDY OBSERVED A HIGHER INCIDENCE OF SOME OF THESE COMPLICATIONS (FOR EXAMPLE, ANASTOMOTIC FISTULA, SEPSIS, NECROSIS) IN THE FEMALE GROUP COMPARED TO MALES. THERE WAS NO INFORMATION REGARDING WHAT MEDICAL INTERVENTION WAS PERFORMED FOR THE COMPLICATIONS. ACCORDING TO THE ARTICLE, THE CAUSE OF HIGHER PREVALENCE OF COMPLICATIONS IN FEMALES IS NOT FULLY UNDERSTOOD, BUT COULD BE RELATED TO HIGHER AGE IN THE FEMALE GROUP, AS WELL AS THE PELVIC ARCHITECTURE, TISSUE VASCULARITY AND HEALING PROCESS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094725 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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