BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 20906028 · Received December 11, 2024

    Report

    Report Number
    2955842-2024-22837
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    June 27, 2024
    Report Date
    November 14, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    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

    BASED ON THE INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATION 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: LONG SX, WANG XN, TIAN SB, BI YF, GAO SS, WANG Y, GUO XB. ROBOTIC-ASSISTED LOW ANTERIOR RESECTION FOR RECTAL CANCER SHOWS SIMILAR CLINICAL EFFICACY TO LAPAROSCOPIC SURGERY: A PROPENSITY SCORE MATCHED STUDY. WORLD J GASTROINTEST SURG 2024; 16(6): 1558-1570. HTTPS://DX.DOI.ORG/10.4240/WJGS.V16.I6.1558. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, A GENERIC X SYSTEM WAS REPORTED.

    Description of Event or Problem · 0

    A RETROSPECTIVE, SINGLE SITE STUDY WHICH REPORTS THAT ROBOTIC-ASSISTED LOW ANTERIOR RESECTION FOR RECTAL CANCER SHOWS SIMILAR CLINICAL EFFICACY TO LAPAROSCOPIC SURGERY, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE AIM OF THE STUDY WAS TO CONDUCT A COMPARATIVE ANALYSIS OF PERIOPERATIVE AND ONCOLOGICAL OUTCOMES BETWEEN ROBOT-ASSISTED AND LAPAROSCOPIC-ASSISTED LOW ANTERIOR RESECTION (LALAR) PROCEDURES. THE STUDY OCCURRED FROM DECEMBER 2019 TO NOVEMBER 2022 AND INCLUDED 125 PATIENTS WHO UNDERWENT ROBOT-ASSISTED LOW ANTERIOR RESECTION (RALAR) AND 279 PATIENTS WHO UNDERWENT LALAR RESECTION. IN THE RALAR GROUP, THERE WERE 76 MALES, 49 FEMALES WITH A MEDIAN AGE OF 62 YEARS AND A MEDIAN BMI OF 24. THE ARTICLE NOTED THAT IN THE ROBOTIC-ASSISTED GROUP THERE WAS ONE CASE OF AN ANASTOMOTIC LEAK, REPORTED AS A CLAVIEN-DINDO GRADE IIIA. THERE WERE NO OTHER DETAILS PROVIDED ABOUT THIS PATIENT OR EVENT. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ANY INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENTS. 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
    1812897 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620 N/A

    Patients

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