BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22201498 · Received June 13, 2025

    Report

    Report Number
    2955842-2025-25251
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 22, 2025
    Report Date
    May 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE THE SYSTEM LOGS WERE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. A CONE BEAM WITH CIOS SPIN WAS PERFORMED AFTER SUCCESSFULLY NAVIGATED TO THE NODULE. WHEN THE SCAN WAS COMPLETED, THE PHYSICIAN REVIEWED IT AND NOTICED A PNEUMOTHORAX. THE PHYSICIAN PROCEEDED WITH THE BIOPSY SINCE HE WAS AT THE RIGHT SPOT. AFTER FINISHING THE ION PORTION OF THE PROCEDURE, A CHEST TUBE WAS PLACED IN THE PATIENT DURING THE SAME PROCEDURE. THE BIOPSY WAS APPROXIMATELY 20 MINUTES AND THERE WAS A DELAY DUE TO THE CHEST TUBE PLACEMENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS LIKELY TO STAY THE NIGHT. THE PHYSICIAN CONFIRMED THAT THE ION SYSTEM DID NOT CAUSE THE PNEUMOTHORAX, SINCE THE PATIENT WAS VERY SICK AND HAD A LOT OF EMPHYSEMA WITH BULLAE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. INTUITIVE SURGICAL INC., (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. HOWEVER, THERE WAS NO RESPONSE RECEIVED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376891 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

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