BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 17659845 · Received August 31, 2023

    Report

    Report Number
    2955842-2023-18119
    Event Type
    Death
    Date Received
    August 31, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 3, 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
    CA, 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. 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.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE. A NEEDLE AND FORCEPS WERE UTILIZED TO BIOPSY A LESION IN THE RIGHT UPPER LOBE AND ON THE PLEURA. A CHEST TUBE WAS PLACED INTRA-OPERATIVELY, THE PATIENT WAS EXTUBATED AND THEN ADMITTED TO THE ICU. THE PATIENT CONTINUED TO WORSEN DUE TO BRONCHORRHEA ASSOCIATED WITH MUCINOUS ADENOCARCINOMA WITH INEFFECTIVE COUGH DUE TO THE CHEST TUBE AND PNEUMOTHORAX, WHICH LED TO WORSENING RESPIRATORY FAILURE AND RE-INTUBATION. PULSE DOSE STEROIDS WERE ADMINISTERED FOR AN UNRESOLVING PNEUMONIA. THE PATIENT CONTINUED TO WORSEN AND ULTIMATELY EXPIRED ON AN UNKNOWN DATE IN THE ICU. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. REVIEW OF THE EVENT BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER CONCLUDED THAT THE PATIENT SUFFERED A PNEUMOTHORAX FOR WHICH A CHEST TUBE WAS PLACED, AND ADMISSION TO ICU AND RE-INTUBATION WERE REQUIRED. THE PATIENT'S CONDITION CONTINUED TO DETERIORATE, THE PNEUMOTHORAX PERSISTED AND THE PATIENT DIED IN THE ICU. BASED ON THE AVAILABLE DATA, THE SUBSEQUENT HOSPITAL COURSE OF PNEUMOTHORAX AND RESPIRATORY FAILURE WAS RELATED TO THE PROCEDURE AND NOT THE ION SYSTEM. THERE WAS 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 OVERALL COMPLICATION RATE, INCLUDING PNEUMOTHORAX. ONE PROSPECTIVE MULTICENTER REGISTRY STUDY OF BRONCHOSCOPIC BIOPSIES OF PERIPHERAL LUNG LESIONS REPORTED 10 PNEUMOTHORACES IN 581 CASES REFLECTING A RATE OF 1.7%. ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF NAVIGATIONAL BRONCHOSCOPY IN 1,215 SUBJECTS REPORTED A TOTAL PNEUMOTHORAX RATE OF 4.3% AND A RATE OF 2.9% REQUIRING HOSPITALIZATION OR INTERVENTION. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED A PNEUMOTHORAX RATE OF 2.5%. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED A PNEUMOTHORAX RATE OF 3.1% WITH A TOTAL OF 7 (1.7%) PATIENTS REQUIRING A CHEST TUBE. FATAL COMPLICATIONS ARE MORE RARE. A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 NAVIGATIONAL BRONCHOSCOPIES REPORTED 1 ASSOCIATED DEATH (0.08%). A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH (0.0096%). A MORE RECENT CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO DEATHS. 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. KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. BROWNLEE AR, WATSON JJJ, AKHMEROV A, ET AL. ROBOTIC NAVIGATIONAL BRONCHOSCOPY IN A THORACIC SURGICAL PRACTICE: LEVERAGING TECHNOLOGY IN THE MANAGEMENT OF PULMONARY NODULES. JTCVS. 2023. SECTION A2: THE PATIENT AGE OF 52 YRS WAS ADDED SINCE THE YEAR OF BIRTH (1971) WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE. A NEEDLE AND FORCEPS WERE UTILIZED TO BIOPSY THE LESION WHICH WAS LOCATED IN THE RIGHT UPPER LOBE ON THE PLEURA. THERE IS 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.

    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
    1513260 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female ION ENDOLUMINAL SYSTEM