BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 25204455 · Received May 18, 2026

    Report

    Report Number
    2955842-2026-25414
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 18, 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
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL OFFICER, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "PATIENT UNDERWENT AN ION PROCEDURE FOR BIOPSY OF A LEFT LOWER LOBE LESION. PATIENT WAS UNABLE TO MOVE THE LEFT SIDE AFTER WAKING UP FROM ANESTHESIA. SUSPECTED ETIOLOGY FOR THE COMPLICATION IS AIR EMBOLISM. NO ADDITIONAL INFORMATION IS AVAILABLE DESPITE MAKING MULTIPLE ATTEMPTS. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE AND RARELY ASSOCIATED FATAL COMPLICATIONS. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH. IN ANOTHER MULTICENTER PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES THE TOTAL NUMBER OF ANY COMPLICATIONS WAS REPORTED TO BE 227 (1.08%) WITH 4 TOTAL DEATHS (0.02%). AIR EMBOLISM IS A RARE BUT KNOWN COMPLICATION OF BRONCHOSCOPIC AND PERCUTANEOUS LUNG BIOPSIES. AIR EMBOLISM HAS BEEN REPORTED TO OCCUR IN 0.06 TO 0.45% OF CASES WITH CT GUIDED LUNG BIOPSIES AND IS ESTIMATED TO OCCUR LESS FREQUENTLY WITH BRONCHOSCOPY. THERE ARE ONLY A HANDFUL OF CASE REPORTS DESCRIBING AIR EMBOLISM ASSOCIATED WITH FLEXIBLE BRONCHOSCOPY. IN A SURVEY OF 103,978 BRONCHOSCOPIES ONLY 1 ARTERIAL AIR EMBOLISM WAS REPORTED (0.00096%) WITH 71 CASES (0.068%) OF ASSOCIATED CARDIOVASCULAR EVENTS. HOWEVER, IT IS POSSIBLE THIS IS AN UNDERESTIMATE AS A FRACTION OF THE CARDIOVASCULAR EVENTS ASSOCIATED WITH BRONCHOSCOPY MAY BE DUE TO ARTERIAL AIR EMBOLISM. THE RISK OF AIR EMBOLISM WITH CT GUIDED LUNG BIOPSY RANGES FROM 0.02-4.8%. IN ONE STUDY OF 559 CASES 27 EVENTS (4.8%) OF AIR EMBOLISM WERE DETECTED WITH OBLIGATORY POST BIOPSY IMAGING WITH ONLY 1 PATIENT (0.18%) BEING SYMPTOMATIC. IN ANOTHER SERIES OF 204 CASES 8 EVENTS OF AIR EMBOLISM WERE DETECTED WITH ONLY 2 BEING SYMPTOMATIC. GIVEN THE AVAILABLE DATA AIR EMBOLISM IS UNLIKELY WITH NEGATIVE IMAGING IN THE SETTING OF SYMPTOMS." KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. ASANO F, AOE M, OHSAKI Y, ET AL. DEATHS AND COMPLICATIONS ASSOCIATED WITH RESPIRATORY ENDOSCOPY: A SURVEY BY THE JAPAN SOCIETY FOR RESPIRATORY ENDOSCOPY IN 2010: COMPLICATIONS OF RESPIRATORY ENDOSCOPY. RESPIROLOGY. 2012. MONNIN-BARES, VALÉRIE, ET AL. SYSTEMIC AIR EMBOLISM DEPICTED ON SYSTEMATIC WHOLE THORACIC CT ACQUISITION AFTER PERCUTANEOUS LUNG BIOPSY: INCIDENCE AND RISK FACTORS. EUROPEAN JOURNAL OF RADIOLOGY. 2019. MAEHARA, YOSUKE, ET AL. "FREQUENCY AND RISK FACTORS FOR AIR EMBOLISM IN COMPUTED TOMOGRAPHY FLUOROSCOPY¿ GUIDED BIOPSY OF LUNG TUMOR WITH THE USE OF NONCOAXIAL AUTOMATIC NEEDLE." JOURNAL OF COMPUTER ASSISTED TOMOGRAPHY. 2023. RICHARDSON, C. M., ET AL. PERCUTANEOUS LUNG BIOPSIES: A SURVEY OF UK PRACTICE BASED ON 5444 BIOPSIES. THE BRITISH JOURNAL OF RADIOLOGY. 2002 FACCIOLONGO N, PATELLI M, GASPARINI S, ET AL. INCIDENCE OF COMPLICATIONS IN BRONCHOSCOPY. MULTICENTRE PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES. MONALDI ARCHIVES FOR CHEST DISEASE. 2009;71(1). TOMIYAMA N, YASUHARA Y, NAKAJIMA Y, ET AL. CT-GUIDED NEEDLE BIOPSY OF LUNG LESIONS: A SURVEY OF SEVERE COMPLICATION BASED ON 9783 BIOPSIES IN JAPAN. EUROPEAN JOURNAL OF RADIOLOGY. 2006. ISHII H, HIRAKI T, GOBARA H, ET AL. RISK FACTORS FOR SYSTEMIC AIR EMBOLISM AS A COMPLICATION OF PERCUTANEOUS CTGUIDED LUNG BIOPSY: MULTICENTER CASE-CONTROL STUDY. CARDIOVASC INTERVENT RADIOL. 2014. HE YP, LIU YL, GAO XL, WANG LH. CEREBRAL ARTERIAL AIR EMBOLISM AFTER ENDOBRONCHIAL ELECTROCAUTERY: A CASE REPORT AND REVIEW OF THE LITERATURE. BMC PULM MED. 2021. A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT POSSIBLY DEVELOPED AN AIR EMBOLISM. THE TARGETED LESION WAS IN THE LEFT LOWER LOBE. THE PATIENT WAS UNABLE TO MOVE THEIR LEFT SIDE AFTER AWAKENING FROM THE ION PROCEDURE. 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; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353920 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| L ION ENDOLUMINAL SYSTEM