BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 19977726 · Received August 13, 2024

    Report

    Report Number
    2955842-2024-18060
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    February 8, 2024
    Report Date
    July 17, 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, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THERE IS INSUFFICIENT INFORMATION ON THE PROCEDURE DATES AND DA VINCI SYSTEM(S) USED; THEREFORE, A SYSTEM LOG WAS NOT AVAILABLE TO BE PERFORMED. SOURCE: "THE REVO-I ROBOTIC SURGICAL SYSTEM IN ADVANCED PANCREATIC SURGERY: A SECOND NON-RANDOMIZED CLINICAL TRIAL AND COMPARATIVE ANALYSIS TO THE DA VINCI¿ SYSTEM" (C.M. KANG ET AL, 2024)

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REVIEWED AN ARTICLE THAT COMPARED THE FEASIBILITY AND SAFETY OF THE REVO-I ROBOT SYSTEM TO DA VINCI SURGICAL SYSTEMS FOR ROBOT-ASSISTED PANCREATICODUODENECTOMIES (RPD) AND THE FOLLOWING COMPLICATIONS WERE MENTIONED: A TOTAL OF 10 PATIENTS UNDERWENT REVO-I ROBOT ASSISTED RPD AND A TOTAL OF 37 PATIENTS UNDERWENT DA VINCI ASSISTED RPD BETWEEN MARCH 2017 AND AUGUST 2020. THERE WAS NO STATISTICAL DIFFERENCE IN THE INTRAOPERATIVE BLOOD LOSS BETWEEN THE TWO GROUPS, BUT THERE WAS ONE CASE OF INTRA-OPERATIVE TRANSFUSION REQUIRED IN THE DA VINCI GROUP. THE DA VINCI GROUP HAD TWO CASES OF CLAVIEN-DINDO GRADE IIIB COMPLICATIONS THAT REQUIRED REOPERATION. ONE PATIENT WAS READMITTED DUE TO INTESTINAL OBSTRUCTION AND UNDERWENT ADHESIOLYSIS AND BYPASS SURGERY, WHILE THE OTHER PATIENT HAD A DRAINAGE CATHETER ISSUE THAT REQUIRED FOREIGN BODY REMOVAL UNDER GENERAL ANESTHESIA. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE POSTOPERATIVE PANCREATIC FISTULA (POPF) RATE BETWEEN THE TWO GROUPS. SEVEN PATIENTS IN THE DA VINCI GROUP WERE READMITTED, INCLUDED THE ONE PATIENT PREVIOUSLY MENTIONED AS REQUIRING REOPERATION, ONE PATIENT WITH EPIGASTRIC DISCOMFORT, AND FIVE PATIENTS WHO REQUIRED PIGTAIL DRAINAGE CATHETER INSERTION DUE TO INTRA-ABDOMINAL ABSCESS IN ASSOCIATION WITH POSTOPERATIVE PANCREATIC FISTULA (POPF). THERE WAS NO MENTION OF DA VINCI DEVICE MALFUNCTION DURING ANY OF THE PROCEDURES IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619373 DA VINCI DA VINCI NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES