BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 16888261 · Received May 8, 2023

    Report

    Report Number
    2955842-2023-12951
    Event Type
    Death
    Date Received
    May 8, 2023
    Date of Event
    April 14, 2023
    Report Date
    April 14, 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
    SC, 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 IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THAT NO RELATED SYSTEM ERRORS 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. MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT AN 82-YEAR-OLD FEMALE UNDERWENT AN ION ENDOLUMINAL BRONCHOSCOPY FOR A LUNG LESION. SHE HAD COMORBIDITIES INCLUDING MODERATE COPD WITH AN FEV1 IN THE 50% OF PREDICTED RANGE ALONG WITH URETERAL AND THYROID CANCERS. NO BIOPSY WAS PERFORMED AS THE TARGET LESION WAS NOT ABLE TO BE IDENTIFIED WHICH THE PHYSICIAN ATTRIBUTED TO THE PATIENT¿S AIRWAY ANATOMY. THE BRONCHOSCOPY WAS COMPLETED WITHOUT ISSUE. ABOUT 10 MINUTES AFTER THE PATIENT WAS EXTUBATED SHE DEVELOPED RESPIRATORY DISTRESS. NONINVASIVE POSITIVE PRESSURE VENTILATION WAS INITIATED BRIEFLY AND NEBULIZED BRONCHODILATORS WERE ADMINISTERED BUT THE PATIENT WAS ULTIMATELY REINTUBATED, AND WENT INTO CARDIAC ARREST. RESUSCITATIVE EFFORTS WERE INITIATED INCLUDING CPR FOR ABOUT 20 MINUTES. NO SHOCKABLE RHYTHM WAS IDENTIFIED AND THE PATIENT DIED. THERE WAS NO ALLEGATION OF MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. THE PHYSICIAN DID NOT THINK THE PROCEDURE CONTRIBUTED TO THE PATIENT¿S RESPIRATORY DISTRESS NOR DEATH. BRONCHOSCOPY 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%). ANOTHER MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO DEATHS ASSOCIATED WITH 581 CASES OF BRONCHOSCOPY WITH BIOPSIES. A MORE RECENT PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%) IN PATIENTS WHO UNDERWENT BRONCHOSCOPY WITH BIOPSIES. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT OR ACCESSORIES ASSOCIATED WITH THE REPORTED EVENT. 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 GENERAL ANESTHESIA IN A PATIENT WITH UNDERLYING MODERATE COPD. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER AN ION ENDOLUMINAL LUNG BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND SUBSEQUENTLY WENT INTO CARDIAC ARREST AND EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION LUNG BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND ULTIMATELY EXPIRED. THE BRONCHOSCOPY WAS COMPLETED; HOWEVER, A BIOPSY WAS NOT PERFORMED AS THE PHYSICIAN WAS UNABLE TO NAVIGATE TO THE LESION DUE TO THE ACUTE CURVATURE OF THE AIRWAYS. ONLY THE VISION PROBE WAS USED IN THE CATHETER THROUGHOUT THE TIME THE ION SYSTEM WAS IN USE. THEREFORE, NO BIOPSY TOOLS WERE USED AT ANY POINT DURING THE PROCEDURE. THE PHYSICIAN REPORTED THAT APPROXIMATELY 10 MINUTES POST PROCEDURE AND AFTER EXTUBATION, THE PATIENT EXPERIENCED RESPIRATORY DISTRESS. BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) AND NEBULIZATION WERE BRIEFLY TRIED BUT THE PATIENT EVENTUALLY REQUIRED INTUBATION. SHORTLY THEREAFTER THE PATIENT WENT INTO CARDIAC ARREST WITH A NON-SHOCKABLE RHYTHM AND CPR WAS ADMINISTERED FOR 20 MINUTES. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL AND THE PATIENT EXPIRED. A DIRECT CAUSE FOR THE EVENT WAS UNKNOWN. THE PATIENT HAD A HISTORY CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PHYSICIAN STATED THAT HE DOES NOT THINK THE ION SYSTEM OR PROCEDURE HAD ANYTHING TO DO WITH THE POST-PROCEDURE EVENTS AS HE COULD NOT COMPLETE THE BIOPSY PROCEDURE. HE STATED THAT NO MALFUNCTION OF ANY ION SYSTEM OR PRODUCT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764942 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female ION ENDOLUMINAL SYSTEM.