BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP SURGICAL SYSTEM

    MDR report key: 23722077 · Received December 4, 2025

    Report

    Report Number
    2955842-2025-47551
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    April 15, 2025
    Report Date
    December 4, 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
    MN, US
    Reporter Occupation
    PHYSICIAN
    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. NO IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALS FIVE RELATED COMPLAINTS REPORTED IN THIS CLINICAL ARTICLE. PLEASE SEE SECTION H10 FOR THE RELATED MANUFACTURER REPORT NUMBERS FOR THE OTHER SERIOUS EVENTS REPORTED IN THE SAME ARTICLE. ADDITIONAL REPORTS NOT CAPTURED IN H10 ARE 2955842-2025-47552 AND 2955842-2025-47553. CITATION: KESHK, N.O.; ET AL COMBINED TATME WITH SP ROBOT FOR LOW ANTERIOR RESECTION IN RECTAL CANCER: RSPA TATME. CANCERS 2025, 17, 1328. HTTPS://DOI.ORG/10.3390/CANCERS17081328. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEAN AGE OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO THE FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 11-NOV-2025. SECTION D: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON AN UNSPECIFIED DAVINCI SP DEVICE. A GENERIC MATERIAL NUMBER IS USED AS THE PRIMARY PRODUCT. .

    Description of Event or Problem · 0

    A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN (B)(6) 2022 AND (B)(6) 2024. ONE PATIENT EXPERIENCED AN ILEUS WHICH WAS MANAGED CONSERVATIVELY, AND AN ACUTE KIDNEY INJURY, WHICH WAS MANAGED WITH HYDRATION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES "NONE OF THE COMPLICATIONS [ARE] RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447131 DA VINCI SP SURGICAL SYSTEM DA VINCI SP SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC 380601 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES