BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 11905533 · Received May 29, 2021

    Report

    Report Number
    2955842-2021-10580
    Event Type
    Injury
    Date Received
    May 29, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 3, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT OF AN ION PROCEDURE EXPIRED WITHIN THE SAME DAY OF THE PROCEDURE. THE ROOT CAUSE OF THE PATIENT DEATH HAS YET TO BE DETERMINED. THERE ARE NO ALLEGATIONS AGAINST AN ION PRODUCT REGARDING THIS EVENT. A MEDICAL REVIEW WAS PERFORMED BY A MEDICAL SAFETY OFFICER OF THIS REPORTED EVENT AND THE FOLLOWING INFORMATION WAS PROVIDED: "GIVEN THE LIMITED INFORMATION, AN ADEQUATE ASSESSMENT OF ROUTE CAUSE AND RELATIONSHIP BETWEEN THE EVENT AND UTILIZED TECHNOLOGIES IS NOT POSSIBLE AT THIS POINT. IN GENERAL, PERI-PROCEDURAL MORTALITY RELATED TO ENDOLUMINAL LUNG BIOPSY PROCEDURES ARE RARE AND MORTALITY IS OFTEN RELATED TO RELEVANT CO-MORBIDITIES, ANESTHESIA OR ADVANCED AGE AS PRESENTED IN THIS (B)(6) PATIENT." THE SYSTEM LOGS WERE PULLED FOR THE ION SYSTEM USED DURING PROCEDURE BY A SENIOR FAILURE ANALYSIS ENGINEER. HOWEVER, THE LOGS FOR SYSTEM (B)(4) ON THE DATE OF THIS PROCEDURE WERE NOT AVAILABLE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS EVENT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT OF AN ION PROCEDURE EXPIRED WITHIN THE SAME DAY OF THE PROCEDURE. THE ROOT CAUSE OF THE PATIENT DEATH HAS YET TO BE DETERMINED. THERE ARE NO ALLEGATIONS AGAINST AN ION PRODUCT REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPIRED WHILE WALKING UP STAIRS. IT WAS REPORTED THAT THE ION PROCEDURE WENT FINE WITH NO COMPLICATIONS. FOLLOW-UP: 05-MAY-2021, AN INTUITIVE SURGICAL INC. (ISI) ENDOLUMINAL TERRITORY ASSOCIATE (ETA) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ION PROCEDURE WAS PERFORMED ON 26-APR-2021 AND THE PATIENT EXPIRED THE SAME EVENING. THE CUSTOMER HAS NOT REPORTED THE CAUSE OF DEATH AND AN AUTOPSY HAD NOT BEEN PERFORMED AS OF 03-MAY-2021. AN ISI REPRESENTATIVE FIRST BECAME AWARE OF THE PATIENT DEATH ON 03-MAY-2021. FOLLOW-UP: ON 11-MAY-2021, AN ISI ETA CONTACTED THE RESPIRATORY THERAPIST OF THE CUSTOMER SITE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PHYSICIAN REPORTED THAT THEY DO NOT THINK THE PATIENT DEATH WAS RELATED TO THE ION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802039 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-44 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR