BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 16215568 · Received January 20, 2023

    Report

    Report Number
    2955842-2023-10204
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    April 14, 2022
    Report Date
    December 21, 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
    NY, 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. ON 22-DEC-2022; AN ADVANCED SYSTEM LOG REVIEW WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). REVIEW OF THE LOGS DID NOT FIND ANY ERRORS THAT ARE RELEVANT TO THE REPORTED EVENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE INSERTION AND HOSPITALIZATION. MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE INSERTION AND HOSPITALIZATION. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080299 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown ION ENDOLUMINAL SYSTEM