BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 16099608 · Received January 4, 2023

    Report

    Report Number
    2955842-2022-16263
    Event Type
    Death
    Date Received
    January 4, 2023
    Date of Event
    December 6, 2022
    Report Date
    December 6, 2022
    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
    AZ, 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 EVENT INFORMATION WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) AND THE FOLLOWING CLINICIAN ASSESSMENT WAS PROVIDED: "A FEMALE PATIENT IN HER 60S OR EARLY 70S UNDERWENT AN ION ROBOTIC BRONCHOSCOPY AND BIOPSY ON (B)(6) 2022. A PREVIOUS ION BIOPSY WAS INTERPRETED AS MALIGNANT BY 2 PATHOLOGISTS (LOCAL AND AT THE (B)(6) CLINIC) BUT INTERPRETED AS NOT DEFINITIVELY MALIGNANT BY A LOCAL SENIOR PATHOLOGIST PROMPTING A SECOND BIOPSY. THE TARGET LESION WAS IN THE LEFT UPPER LOBE OVER 3 CM AWAY FROM THE PLEURA. REGISTRATION, NAVIGATION AND BIOPSY OF THE LESION WERE UNREMARKABLE. INTEGRATED CONE BEAM CT IMAGING WAS PERFORMED TO ENSURE THE TARGET LESION WAS BIOPSIED. BIOPSIES OBTAINED WERE TYPICAL INCLUDING NEEDLE ASPIRATION, NEEDLE CYTOLOGY BRUSHING, AND FORCEPS. CYTOLOGIC EVALUATION OF INITIAL SAMPLES WERE NOTABLE FOR ATYPICAL CELLS PROMPTING PATHOLOGY TO REQUEST FURTHER BIOPSIES WHICH WERE OBTAINED. THE BIOPSIES WERE COMPLETED AND DURING ION CATHETER RETRACTION INTO THE ETT THE PATIENT A CARDIAC ARREST. BLOOD WAS NOTED IN THE ETT. RETURN OF SPONTANEOUS CIRCULATION WAS NOT ACHIEVED AND THE PATIENT DIED AFTER THE PROCEDURE. BASED ON THE PARTIAL DATA AVAILABLE FOR REVIEW THE CAUSE OF DEATH IS UNKNOWN. WHETHER THE EVENT WAS DIRECTLY RELATED TO THE ION BIOPSY IS ALSO UNKNOWN." ON (B)(6) 2022, PER AN ISI ADVANCED FAILURE ENGINEER, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY WENT INTO CARDIAC ARREST WHILE THE CATHETER WAS BEING REMOVED FROM THE PATIENT. ADVANCED CARDIAC LIFE SUPPORT WAS INITIATED AND PERFORMED FOR 45 MINUTES. ULTIMATELY, THE PATIENT EXPIRED. THE CAUSE OF THE CARDIAC ARREST IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY WENT INTO CARDIAC ARREST WHILE THE CATHETER WAS BEING REMOVED FROM THE ENDOTRACHEAL TUBE. THERE WAS BLEEDING NOTED, WHICH STARTED SLOWLY AT FIRST. THERE WAS NO PALPABLE RADIAL PULSE. ADVANCED CARDIAC LIFE SUPPORT WAS INITIATED AND PERFORMED FOR 45 MINUTES. ULTIMATELY, THE PATIENT EXPIRED. THE TARGET NODULE WAS IN THE LEFT UPPER LOBE, LOWER LATERAL SEGMENT, AND NOT IN CLOSE PROXIMITY TO THE PLEURA. THE PATIENT HAD BILATERAL LESIONS; HOWEVER, THE PHYSICIAN DECIDED TO BIOPSY ONLY ONE LESION. THERE WERE OVER 10 BIOPSIES DONE FOR THAT SITE, AND THERE WERE MANY PASSES MADE (CLOUD BIOPSY) USING A NEEDLE, NEEDLE BRUSH AND FORCEPS. PATHOLOGY MENTIONED THAT MANY OF THE SAMPLES CONTAINED NECROTIC TISSUE, BUT THE USER WAS ULTIMATELY ABLE TO GET A SATISFACTORY SAMPLE. A CIOS SPIN C-ARM WAS USED DURING THE CASE. THERE WERE NO REPORTED ANESTHESIA ISSUES, NO ERROR MESSAGES, NO TECHNICAL DIFFICULTIES, AND NO CT TO BODY DIVERGENCE EXPERIENCED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288362 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ION ENDOLUMINAL SYSTEM