BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 13206302 · Received January 10, 2022

    Report

    Report Number
    2955842-2022-10030
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    December 13, 2021
    Report Date
    December 13, 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
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE SYSTEM LOGS WERE REVIEWED FOR THE ION SYSTEM (B)(4) ON THE PROCEDURE DATE OF (B)(6) "202" BY AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE PATIENT'S HEART RATE WAS FLUCTUATING. THE PATIENT WAS CONSIDERED UNSTABLE AT A CERTAIN POINT AND WAS HOSPITALIZED OVERNIGHT. ALTHOUGH THE PHYSICIAN INDICATED THAT THE COMPLICATION HAD NOTHING TO DO WITH ION, THE CAUSE IF THE PATIENT'S HEART RATE FLUCTUATING IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE PATIENT'S HEART RATE WAS FLUCTUATING. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THESE ISSUES AFTER THE COMPLETION OF THE ION PORTION OF THE PROCEDURE (ION UNDOCKED FROM PATIENT) AND WHILE THE CUSTOMER WAS USING A RADIAL EBUS. THE PHYSICIAN DID NOT COMPLETE THE EBUS PORTION OF THE PROCEDURE DUE TO THIS EVENT. THE PATIENT WAS STABILIZED AND WAS HOSPITALIZED OVERNIGHT TO RECOVER. ON 20-DEC-2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE PHYSICIAN OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PHYSICIAN REPORTED: "THIS EVENT HAD NOTHING TO DO WITH THE ION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963606 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-45 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ION ENDOLUMINAL SYSTEM.