BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 23593230 · Received November 19, 2025

    Report

    Report Number
    2955842-2025-45211
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    February 19, 2025
    Report Date
    November 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. NO INVESTIGATION COULD BE PERFORMED AS THE MEDWATCH REPORT DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE REPORTER INFORMATION, PROCEDURE DATE OR DA VINCI PRODUCT OR SYSTEM IDENTIFIERS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE REPORT MW5166775 STATING: "VESSEL SEALER SPLIT APART AND PUNCTURED THROUGH PATIENT NEXT TO TROCAR INCISION. PHYSICIAN REMOVED AND REPAIRED." THE REPORT DID NOT PROVIDE ANY CONTACT INFORMATION AND/OR DETAILS FOR ISI TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297558 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 N/A

    Patients

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