BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21508892 · Received March 3, 2025

    Report

    Report Number
    2955842-2025-04096
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K150837
    Removal / Correction Number
    ISIFA2022-05-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE EVENT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, A SMALL CLIP APPLIER INSTRUMENT. WHILE ATTEMPTING TO CLIP A SMALL VESSEL WITHIN THE LIVER, THE INSTRUMENT "JERKED" RIGHT AS THE CLIP WAS TO BE APPLIED. THIS LED TO MORE DIFFICULTY GAINING CONTROL OF BLEEDING BUT WAS UNCLEAR IF THE UNINTENDED MOVEMENT CAUSED ADDITIONAL BLEEDING OR INJURY. THE INSTRUMENT WAS TAKEN OFF THE STERILE FIELD AND TAGGED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FURTHER EVALUATION. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE PATIENT IS RECOVERING AS EXPECTED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586042 ENDOWRIST CLIP APPLIER, SMALL, HORIZON NAY INTUITIVE SURGICAL, INC 470401-07 T10190801 0047

    Patients

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