BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI SURGICAL SYSTEM

    MDR report key: 23706399 · Received December 3, 2025

    Report

    Report Number
    2955842-2025-46219
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    April 22, 2025
    Report Date
    December 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 SP SYSTEM IDENTIFIERS. NO IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. THIS EVENT CAPTURES THE REPORTED SERIOUS INJURY COMPLICATIONS. PLEASE SEE SECTION H10 FOR THE RELATED MANUFACTURER REPORT NUMBERS FOR THE DEATH REPORTED IN THE SAME ARTICLE. SECTION A: PATIENT AGE: REFLECTS THE STUDY MEAN AGE IN YRS. ARTICLE REPORTS THAT THE MEAN AGE OF THE POPULATION WAS 60.2 ± 11.3 YEARS. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS (B)(6) 2025. SECTION D: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. CITATION: CHOI, Y. J., JEON, S. M., YU, S., JO, H., KIM, D., & YU, Y. (2025). INITIAL EXPERIENCE OF ROBOTIC-ASSISTED PANCREATICODUODENECTOMY USING THE DA VINCI SP SYSTEM. SURGICAL ENDOSCOPY, 39(6), 4017¿4025. HTTPS://DOI.ORG/10.1007/S00464-025-11695-4.

    Description of Event or Problem · 0

    A REVIEW OF AN ARTICLE WAS CONDUCTED, WHICH AIMED TO EVALUATE THE INITIAL EXPERIENCE AND FEASIBILITY OF ROBOTIC-ASSISTED PYLORUS-PRESERVING PANCREATICODUODENECTOMY PROCEDURES (PPPD) USING THE DA VINCI SP SYSTEM VERSUS THE DA VINCI XI SYSTEM. THE STUDY WAS A RETROSPECTIVE CASE SERIES ANALYZING 14 PATIENTS UNDERGOING PPPD FROM DECEMBER 2021 AND SEPTEMBER 2023. A TOTAL OF 2 PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING GRADE B POSTOPERATIVE PANCREATIC FISTULA AND ONE BILE LEAK. THERE WAS NO REPORT OR INDICATION IN THE ARTICLE OF ANY DA VINCI SP SYSTEM MALFUNCTIONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CORRESPONDING AUTHOR WERE MADE; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855097 DAVINCI SI SURGICAL SYSTEM PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES.