BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 15692213 · Received October 28, 2022

    Report

    Report Number
    2955842-2022-14946
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    September 30, 2022
    Report Date
    September 30, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. PER AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER, AS OF 06-OCT-2022, A SYSTEM LOG REVIEW COULD NOT 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: DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, A PATIENT EXPERIENCED A CARDIAC ARREST. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT WAS DISCHARGED HOME AFTER 2 DAYS. THE CAUSE OF THE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE PATIENT CODED, BUT IT WAS NOT DUE TO THE ION SYSTEM. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN EXPLAINED THAT THE PATIENT HAD NOT HAD MEDICAL CARE IN 40 YEARS AND WAS GENERALLY "A SICK PERSON." THE PATIENT REFUSED SUBSTANTIAL TREATMENT AND ADDITIONAL MEDICAL EVALUATION FOR THE CARDIOVASCULAR EVENT AND REQUESTED TO GO HOME. THE PATIENT WAS HOSPITALIZED FOR 2 DAYS AND THEN DISCHARGED HOME. THE PHYSICIAN INDICATED THAT THE CARDIAC ARREST WAS NOT RELATED TO THE ION PROCEDURE, BUT DUE TO THE PATIENT'S POOR HEALTH. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2920467 ION ASSY,SYSTEM,1.6,IF1000 EOQ INTUITIVE SURGICAL, INC 380707-52 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female ION ENDOLUMINAL SYSTEM