BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION

    MDR report key: 24299549 · Received February 9, 2026

    Report

    Report Number
    2955842-2026-03737
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874124796
    PMA / PMN Number
    K212048
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FULL ARTICULATING CATHETER WAS ANALYZED AND FOUND WITH NO EXTERNAL/PHYSICAL DAMAGE. THE CATHETERS HOUSING, TOOL CHANNEL, SENSOR CONNECTOR, ALL INPUT DISK (NO FRICTION), SHAFT COLLAR, AND DISTAL TIP RING WERE ALL INTACT. NO RATTLING NOISE WAS OBSERVED INSIDE THE CATHETER HOUSING WHEN MANUALLY SHAKEN. NO MISSING MATERIAL OR COMPONENT WAS OBSERVED. THE REPORTED/MENTIONED SMALL METAL PIECE BY THE CUSTOMER FOUND IN THE TRAY WAS NOT RETURNED WITH THE CATHETER. THE CATHETER PASSED ALL CONTINUITY TEST DURING IN-HOUSE TESTING. PERFORMED ELECTRICAL CONTINUITY, FULL CONTINUITY LEAKAGE TEST, OD LEAKAGE TEST AND ID CONTINUITY LEAKAGE TEST WITH NO FAILURES. THE CONTINUITY FULL LEAK TEST WAS PERFORMED TWICE AND PASSED ON BOTH ATTEMPTS. THE CATHETER PASSED AIR LEAK TEST TWICE IN-HOUSE WITH NO STREAMING BUBBLES OBSERVED. THE FIBER WAS INSPECTED USING THE EXFO SCOPE, FIBERS APPEARED SMOOTH, NO SIGNS OF DAMAGE AFTER SECOND WET CLEANING. THE CATHETER WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS FOUND. THE COMPLAINT REGARDING A SMALL METAL PIECE WAS FOUND IN THE BOTTOM OF THE TRAY WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT A SMALL METAL PIECE WAS FOUND IN THE BOTTOM OF A TRAY. THE CUSTOMER REPORTED TO BE UNSURE IF IT HAD BROKEN OFF THE CATHETER OR THE VISION PROBE. IT WAS INDICATED THAT THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, INJURY OR PROCEDURAL DELAY. NO FRAGMENT FELL INTO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NURSE WAS ONLY MADE AWARE OF THE SMALL PIECE OF METAL IN THE TRAY ONCE THE OPERATING LISTS WAS FINISHED AND STERILE SERVICES RECEIVED THE TRAY FOR REPROCESSING. THE INSTRUMENTS HAVE BEEN INSPECTED, AND IT COULD NOT BE SEEN ANY PLACE THE METAL HAD COME FROM. NURSE CONTACTED THE PHYSICIAN AND SHE SAID THAT DID NOT NOTICE ANYTHING OF CONCERN AND WAS NOT AWARE THAT A PIECE OF METAL HAD BEEN FOUND.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359640 ION CATHETER EOQ INTUITIVE SURGICAL, INC 490305-21 M12251013 0007 00886874124796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ION ENDOLUMINAL SYSTEM.