BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24284904 · Received February 6, 2026

    Report

    Report Number
    2955842-2026-03195
    Event Type
    Injury
    Date Received
    February 6, 2026
    Report Date
    February 6, 2026
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS ADVERSE EVENT. THERE IS NO INDICATION THAT THE CUSTOMER REPORTED COMPLICATION OF BLEEDING WAS RELATED TO A PRODUCT ISSUE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE PROCEDURE BASED ON THE REVIEWED CLINICAL FEEDBACK. AN ION PRODUCT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW. NO CHANGES NEED TO BE MADE TO THE PRODUCT OR QMS PROCESSES. THIS ADVERSE EVENT IS ASSOCIATED WITH AN UNSPECIFIED HAZARD. NO ADDITIONAL ACTIONS ARE REQUIRED AS THIS KNOWN COMPLICATION WILL CONTINUE TO BE TRACKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. THE PHYSICIAN STATED THAT THE BLEEDING INCIDENT WAS MINOR AND UNEVENTFUL. ADDITIONALLY, THE PHYSICIAN STATED THAT THE COMPLICATION WAS NOT RELATED AT ALL TO THE ION SYSTEM, AND THERE WAS NO ADDITIONAL INFORMATION SHE WISHED TO PROVIDE SINCE IT DID NOT RELATE TO THE FUNCTION OF THE ION SYSTEM. THE PATIENT REPORTEDLY HAD EXISTING UNSPECIFIED LIVER ISSUES WHICH CONTRIBUTED TO THE BLEEDING. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE AND SOURCE OF THE BLEEDING, THE BLOOD LOSS VOLUME, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346458 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

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