BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20739906 · Received November 20, 2024

    Report

    Report Number
    2955842-2024-22153
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    April 24, 2024
    Report Date
    October 28, 2024
    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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SPECIFIC INFORMATION REGARDING THE PROCEDURE SITE OR DATE WAS PROVIDED; THEREFORE, NO DA VINCI SYSTEM OR ACCESSORIES LOG FILES ARE AVAILABLE. SULAIMAN, M., ALI, K.A., CHUNGUANG, Y. ET AL. OPEN VERSUS ROBOT-ASSISTED RETROPERITONEAL TUMORS RESECTION INVOLVING INFERIOR VENA CAVA, ABDOMINAL AORTA, AND RENAL HILUM: A COMPARATIVE STUDY. SURG ENDOSC 38, 3288¿3295 (2024). HTTPS://DOI.ORG/10.1007/S00464-024-10848-1 BLANK MDR FIELDS: FIELDS A2-A6 WERE LEFT BLANK, HOWEVER, THE ARTICLE STATED THAT OF THE 172 PATIENTS THAT UNDERWENT RETROPERITONEAL TUMOR RESECTIONS, THE MEDIAN AGE WAS 50 YEARS WITH A MEDIAN BMI OF 23.5. THE GENDER DISTRIBUTION WAS 50% FEMALE AND 50% MALE. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE WAS PERFORMED WHICH INVOLVED A COMPARATIVE COHORT STUDY. THE AIM OF THE STUDY WAS TO COMPARE THE SHORT-TERM OUTCOMES ASSOCIATED WITH ROBOTIC VERSUS OPEN RESECTION OF RETROPERITONEAL TUMORS, WITH A FOCUS ON PERIOPERATIVE VARIABLES SUCH AS BLOOD LOSS, HOSPITAL STAY, AND COMPLICATIONS. THE SURGERIES WERE PERFORMED BETWEEN MARCH 2018 AND DECEMBER 2022. THE STUDY INCLUDED 104 PATIENTS WHO UNDERWENT ROBOTIC RESECTION AND 68 PATIENTS WHO UNDERWENT OPEN RESECTION. THE ARTICLE NOTED THAT DURING THESE SURGERIES, THREE PATIENTS FROM THE ROBOTIC GROUP EXPERIENCED LYMPHATIC LEAKAGE AND RECEIVED TREATMENT IN ACCORDANCE WITH HOSPITAL GUIDELINES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970273 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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