BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 21862636 · Received April 17, 2025

    Report

    Report Number
    2955842-2025-15496
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    October 19, 2024
    Report Date
    March 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: KIM, MH, ET AL. SHORT-TERM OUTCOMES OF DA VINCI SP VERSUS XI FOR RECTAL CANCER SURGERY: A PROPENSITY SCORE MATCHING ANALYSIS OF TWO TERTIARY CENTER COHORTS. SURGICAL ENDOSCOPY (2025) 39:162-170. DOI.ORG/10.1007/S00464-024-11372-Y. IN SECTION B3, THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS; THUS, A GENERIC XI SYSTEM WAS REPORTED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE "SHORT-TERM OUTCOMES OF DA VINCI SP VERSUS XI FOR RECTAL CANCER SURGERY: A PROPENSITY SCORE MATCHING ANALYSIS OF TWO TERTIARY CENTER COHORTS" DESCRIBED A RETROSPECTIVE ANALYSIS. PATIENTS WHO UNDERWENT ROBOTIC SURGERY FOR RECTAL ADENOCARCINOMA FROM JANUARY 2016 TO SEPTEMBER 2023 AT TWO TERTIARY REFERRAL CENTERS WERE INCLUDED IN THE ANALYSIS. A TOTAL OF 378 PATIENTS WERE ANALYZED: 65 PATIENTS UNDERWENT DA VINCI-ASSISTED SP RECTAL CANCER SURGERY AND 378 PATIENTS UNDERWENT DA VINCI-ASSISTED XI RECTAL CANCER SURGERY. THE STUDY WAS CONDUCTED TO COMPARE KEY PARAMETERS BETWEEN PATIENT COHORTS BEFORE AND AFTER PROPENSITY SCORE MATCHING. THE ARTICLE MENTIONED THAT THERE WERE NO DIFFERENCES IN COMPLICATION RATES AND MAJOR COMPLICATION RATES. THE ARTICLE NOTED THAT IN THE SP GROUP, THE COMPLICATIONS INCLUDED 4 CASES OF ANASTOMOSIS LEAKS WHICH WERE TREATED WITH DIVERSION ILEOSTOMY, AND 2 CASES OF OTHER UNKNOWN COMPLICATIONS. THERE WERE NO INSTANCES OF INTRA-ABDOMINAL ABSCESS/FLUID COLLECTION, ILEUS, OR POSTOPERATIVE BLEEDING. ADDITIONALLY, THERE WAS 1 CASE OF READMISSION. THE AUTHORS CONCLUDED THAT THE DA VINCI SP SYSTEM CONTINUES TO OFFER MINIMAL INVASIVE BENEFITS IN RECTAL CANCER SURGERY. HOWEVER, THE DA VINCI XI SYSTEM¿S INSTRUMENT DIVERSITY PROVIDES A CERTAIN ADVANTAGE, PARTICULARLY IN CASES INVOLVING LOW-LYING RECTAL TUMORS. TAILORING ROBOTIC APPROACHES BASED ON INDIVIDUAL PATIENT CHARACTERISTICS REMAINS PIVOTAL FOR OPTIMIZING OUTCOMES OF RECTAL CANCER SURGERY. NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHOR DID NOT ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. HOWEVER, NO RESPONSE WAS RECEIVED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30103 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601 UNKNOWN

    Patients

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