BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 17075199 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15992
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 11, 2023
    Report Date
    May 12, 2023
    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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. 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. A REVIEW OF THE EVENT INFORMATION WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND THE FOLLOWING WAS NOTED ON (B)(6) 2023: A 76-YEAR-OLD PATIENT UNDERWENT AN ION ENDOLUMINAL BIOPSY. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AND POST PROCEDURE FLUOROSCOPIC IMAGING REVEALED NO PNEUMOTHORAX. AFTER THE ION SYSTEM WAS REMOVED AND MANUAL BRONCHOSCOPY WAS BEING PERFORMED THE PATIENT SUFFERED A CARDIAC ARREST. ACLS WAS ADMINISTERED INCLUDING CPR AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED. POST RESUSCITATION REPEAT FLUOROSCOPY REVEALED A PNEUMOTHORAX WHICH WAS NOT PRESENT ON FLUOROSCOPY AT THE END OF THE ION BIOPSY AND WAS THEREFORE ATTRIBUTED TO RESUSCITATIVE EFFORTS INCLUDING CHEST COMPRESSIONS. THE PATIENT IS CURRENTLY STILL HOSPITALIZED AT THE TIME OF THIS REVIEW TO THE BEST OF OUR KNOWLEDGE. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE AND RARELY ASSOCIATED FATAL COMPLICATIONS. IN A 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%). A MULTICENTER STUDY OF 581 CASES REPORTED 13 (2.2%) COMPLICATIONS WITH NO DEATHS. A RECENT PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 NAVIGATIONAL BRONCHOSCOPIES REPORTED 1 ASSOCIATED DEATH (0.08%). ANOTHER SURVEY-BASED STUDY OF 103,978 BRONCHOSCOPIES DESCRIBED 71 CASES (0.068%) OF ASSOCIATED CARDIOVASCULAR EVENTS. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT OR ACCESSORIES ASSOCIATED WITH THE REPORTED COMPLICATION. THE AVAILABLE DATA SUGGESTS THAT THE ION SYSTEM DID NOT CONTRIBUTE TO THE ADVERSE EVENT, BUT IT IS POSSIBLE THE ADVERSE EVENT WAS RELATED TO THE PROCEDURE INCLUDING ANESTHESIA IN A PATIENT WITH SEVERE UNDERLYING EMPHYSEMA. 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). OST DE, ERNST A, LEI X, ET AL. DIAGNOSTIC YIELD AND COMPLICATIONS OF BRONCHOSCOPY FOR PERIPHERAL LUNG LESIONS. RESULTS OF THE AQUIRE REGISTRY. AM J RESPIR CRIT CARE MED. 2016;193(1):68-77. FOLCH EE, PRITCHETT MA, NEAD MA, ET AL. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR PERIPHERAL PULMONARY LESIONS: ONE-YEAR RESULTS OF THE PROSPECTIVE, MULTICENTER NAVIGATE STUDY. JOURNAL OF THORACIC ONCOLOGY. 2019.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: B5. ADD¿L INFO: THE PATIENT SURVIVED THE ARREST, WENT TO ICU AND WAS EXTUBATED, BUT THEN CHOSE COMFORT MEASURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT CODED. THE LESION SIZE WAS 1.2 CM AND IN THE RIGHT MIDDLE LOBE. TOOLS UTILIZED INCLUDED A 23G FLEXISION NEEDLE WITH COMPATIBLE FORCEPS AND CYTOLOGY BRUSH. TWENTY-FIVE MINUTES INTO THE CASE, THE PHYSICIAN COMPLETED THE BIOPSY, TOOK A POST-PROCEDURE X-RAY SHOT TO CHECK FOR A PNEUMOTHORAX, AND WHILE NAVIGATING DOWN WITH THE SCOPE THE PATIENT FLATLINED. UNSPECIFIED MEDICATION WAS ADMINISTERED, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT WAS REVIVED, AND A SECOND FLUOROSCOPY SHOT WAS PERFORMED, WHICH SHOWED A PNEUMOTHORAX. THE PHYSICIAN BELIEVED THE REASON THE PATIENT CODED WAS DUE TO SEVERE EMPHYSEMA, AND, THEREFORE, THE PNEUMOTHORAX LIKELY RESULTED FROM THE CHEST COMPRESSIONS. DIAGNOSIS OBTAINED FROM PATHOLOGY WAS ATYPICAL CELLS (NON-DIAGNOSTIC). THE PATIENT WAS BEING HELD FOR OBSERVATION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735130 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown ION ENDOLUMINAL SYSTEM