BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 21911734 · Received April 25, 2025

    Report

    Report Number
    2955842-2025-17074
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    November 7, 2024
    Report Date
    March 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: ITO, H., ET AL. INTERIM ANALYSIS OF ROBOT-ASSISTED RADICAL HYSTERECTOMY IN JAPAN: A MULTICENTER, PROSPECTIVE INTERVENTIONAL SINGLE-ARM CLINICAL TRIAL. BIOMED CENTRAL (2024) 24:1360. DOI.ORG/10.1186/S12885-024-13090-Z. THE MISSING PATIENT/DEVICE INFORMATION IN SECTIONS A, B, AND D WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE MEAN AGE AND BODY MASS INDEX OF THE PATIENTS WERE 47 YEARS AND 22 KG/M2.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE "INTERIM ANALYSIS OF ROBOT-ASSISTED RADICAL HYSTERECTOMY IN JAPAN: A MULTICENTER, PROSPECTIVE INTERVENTIONAL SINGLE-ARM CLINICAL TRIAL" WAS PERFORMED. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF ROBOT-ASSISTED RADICAL HYSTERECTOMY (RARH) USING THE DA VINCI SURGICAL SYSTEM (DVSS) COMPARED TO CONVENTIONAL RADICAL HYSTERECTOMY (RH). A PROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED, PERFORMING 292 RASS BETWEEN MARCH 2009 AND DECEMBER 2015. THE SURGERIES WERE PERFORMED USING THE DVSS S, SI, OR XI MODELS. THE MEAN AGE AND BODY MASS INDEX OF THE PATIENTS WERE 47 YEARS AND 22 KG/M2, RESPECTIVELY. THE ARTICLE NOTED THAT DURING THESE DV SURGERIES, SEVERAL SERIOUS ADVERSE EVENTS WERE NOTED. THE SERIOUS PERIOPERATIVE AND POSTOPERATIVE ADVERSE EVENTS OBSERVED INCLUDED URINARY TRACT, VASCULAR, INTESTINAL AND NERVE INJURIES; AND PELVIC INFLAMMATORY DISEASE (PID), URINARY TRACT INFECTION, ILEUS, VAGINAL CUFF DEHISCENCE, AND PULMONARY EMBOLISM. NO CASES WERE CONVERTED TO OPEN SURGERY AND NO DEATHS WERE REPORTED 1 YEAR POSTOPERATIVELY. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED FOR THESE EVENTS, NOR DID THE AUTHOR ALLEGE THAT OTHER INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811671 DA VINCI SURGICAL SYSTEM DA VINCI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES