BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22127295 · Received June 2, 2025

    Report

    Report Number
    2955842-2025-22273
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    May 3, 2025
    Report Date
    May 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116234
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "A 81-YEAR-OLD PATIENT UNDERWENT AN ION LUNG BIOPSY. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AND THE PATIENT WAS EXTUBATED. ONE HOUR AFTER THE PROCEDURE AN ISCHEMIC STROKE DEVELOPED FOR WHICH THROMBOLYSIS WAS PERFORMED. PER THE LAST REPORT THE PATIENT WAS IMPROVING ON THE STROKE WARD. BASED ON THE AVAILABLE DATA THE EVENTS REPORTED WERE POSSIBLY PROCEDURE RELATED BUT NOT DEVICE RELATED. THE STROKE TEAM OPINED THAT THERE WAS NO CAUSALITY BETWEEN THE ION PROCEDURE AND THE STROKE. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT OR ACCESSORIES ASSOCIATED WITH THE REPORTED COMPLICATION. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE. IN A MULTICENTER PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES THE TOTAL NUMBER OF ANY COMPLICATIONS WAS REPORTED TO BE 227 (1.08%) WITH 5 (0.02%) TRANSIENT ISCHEMIC ATTACKS AND 4 (0.02%) TOTAL DEATHS BUT NO STROKES. ANOTHER MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO STROKES AND NO DEATHS ASSOCIATED WITH 581 CASES. A RECENT PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 BRONCHOSCOPIES REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO STROKES. ANOTHER PROSPECTIVE SERIES OF 415 ION PROCEDURES REPORTED 1 CVA (0.2%). THE RISK OF STROKE ASSOCIATED WITH GENERAL ANESTHESIA HAS BEEN REPORTED TO VARY FROM 0.1-1.9% IN NON-CARDIAC, NON-NEUROLOGIC, AND NON-MAJOR SURGERY AND AS HIGH AS 10% IN THE SETTING OF BRAIN OR HIGH-RISK CARDIOVASCULAR SURGERY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A STROKE. THE BIOPSIED LOBE WAS LOCATED IN THE RIGHT UPPER LOBE. THERE WERE NO BREATH HOLD AND NO ATRIAL FIBRILLATION (AF). THE ION PROCEDURE WAS AN UNCOMPLICATED AND SHORT BIOPSY CASE. THERE WERE NO ISSUES WITH THE PROCEDURE. THE PATIENT WAS EXTUBATED AND DOING WELL IN RECOVERY. JUST OVER AN HOUR LATER, THE PATIENT EXPERIENCED A MASSIVE METABOLIC ISCHEMIC STROKE. RAPID STROKE IDENTIFICATION OCCURRED AND THE PATIENT WAS TRANSFERRED TO THE STROKE UNIT AND GIVEN THROMBOLYSIS. REVIEW BY THE STROKE TEAM RESULTED IN NO CAUSATION OF THE ION PROCEDURE TO THE STROKE, BUT LIKELY CARDIOEMBOLIC SOURCE WITH NO OBVIOUS PREOPERATIVE RISK FACTORS (CAROTID STENOSIS, ATRIAL FIBRILLATION, BLOOD THINNING DRUGS STOPPED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479525 ION ASSY,SYSTEM,1.6,IF1000 (CE) NAY INTUITIVE SURGICAL, INC 380748-65 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention| L ION ENDOLUMINAL SYSTEM