BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION

    MDR report key: 21837152 · Received April 14, 2025

    Report

    Report Number
    2955842-2025-14811
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 20, 2025
    Report Date
    March 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K212048
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT THE CATHETER WAS JUMPING ON THE SCREEN. THE CUSTOMER STATED THAT THEY WERE NEAR THE AORTIC ARCH, SO THE PHYSICIAN ONLY PERFORMED 2-3 BIOPSIES AND DID NOT FEEL COMFORTABLE TAKING ANY ADDITIONAL BIOPSIES WITH THE CATHETER. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE CATHETER ON THE MONITOR MOVED ON ITS OWN WITHOUT THE PHYSICIAN TOUCHING THE CONTROLLER AND THE PASSIVE MODE BUTTON WAS NOT PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117232 ION CATHETER EOQ INTUITIVE SURGICAL, INC 490105 N/A

    Patients

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