BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 18044715 · Received October 31, 2023

    Report

    Report Number
    2955842-2023-19726
    Event Type
    Death
    Date Received
    October 31, 2023
    Date of Event
    February 10, 2023
    Report Date
    October 6, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS FOUND THAT NO RELATED SYSTEM ERRORS OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO NON-CONFORMANCES IDENTIFIED TO BE RELATED TO THE EVENT. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, A PNEUMOTHORAX WAS DIAGNOSED BY CHEST X-RAY PRIOR TO EXTUBATION FOR WHICH A CHEST TUBE WAS PLACED. THE PATIENT REMAINED INTUBATED, DEVELOPED REFRACTORY HYPOXIA, AND DIED AFTER A 2-WEEK HOSPITAL COURSE. OF NOTE, THE PATIENT HAD SIGNIFICANT MEDICAL COMORBIDITIES INCLUDING PROGRESSIVE CYSTIC INTERSTITIAL LUNG DISEASE. THE TREATING PHYSICIAN FELT THE PNEUMOTHORAX WOULD LIKELY HAVE OCCURRED VIA ANOTHER BIOPSY MODALITY AND THE PATIENT¿S DEATH WAS RELATED TO THE PATIENT¿S UNDERLYING LUNG DISEASE. (B)(4). THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT OR ACCESSORIES ASSOCIATED WITH THE REPORTED COMPLICATION. BASED ON THE AVAILABLE DATA THE REPORTED PNEUMOTHORAX IS A KNOWN AND EXPECTED COMPLICATION OF THE PROCEDURE. BASED ON THE AVAILABLE DATA THE PATIENT¿S DEATH IS ASSOCIATED WITH THE PROCEDURE IN THE SETTING OF SIGNIFICANT UNDERLYING LUNG DISEASE AND NOT ASSOCIATED WITH THE DEVICE. OST DE, ERNST A, LEI X, ET AL. DIAGNOSTIC YIELD AND COMPLICATIONS OF BRONCHOSCOPY FOR PERIPHERAL LUNG LESIONS. RESULTS OF THE ACQUIRE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE. THE PULMONOLOGIST REPORTED THAT THE TARGET NODULE WAS IN THE RIGHT MIDDLE LOBE, LATERAL SEGMENT, ADJACENT TO THE PLEURA, AND WAS 1.5 CENTIMETERS IN SIZE. FORCEPS BIOPSY WAS USED WITH THE ION NAVIGATIONAL BRONCHOSCOPY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO DELAYS. THE BIOPSY RESULTS FOUND MALIGNANT ADENOCARCINOMA. A PNEUMOTHORAX WITH A 50% RIGHT LUNG COLLAPSE WAS DISCOVERED VIA CHEST X-RAY AFTER THE PROCEDURE. THE PATIENT REQUIRED CHEST TUBE PLACEMENT AND WAS KEPT INTUBATED AND VENTILATED. THE PATIENT DEVELOPED VENTILATOR DESYNCHRONY WITH HIGH PEAK PRESSURES THAT CONTRIBUTED TO THE PNEUMOTHORAX. THE PATIENT SUBSEQUENTLY DEVELOPED REFRACTORY HYPOXEMIA FOLLOWING APPROXIMATELY TWO WEEKS IN THE HOSPITAL. THEIR CONDITION DETERIORATED, AND THE PATIENT SUBSEQUENTLY EXPIRED. THE PATIENT HAD A HISTORY OF ADVANCED, PROGRESSIVE, CYSTIC INTERSTITIAL LUNG DISEASE. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS NOT RELATED TO THE ION SYSTEM. THE PATIENT OUTCOME WAS ATTRIBUTED TO THEIR UNDERLYING MEDICAL CONDITION. THE PHYSICIAN REPORTED THAT THE PNEUMOTHORAX WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033406 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown ION ENDOLUMINAL SYSTEM