BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 16777867 · Received April 20, 2023

    Report

    Report Number
    2955842-2023-12088
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 3, 2023
    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 SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED A TRANSIENT ISCHEMIC ATTACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED TRANSIENT ISCHEMIA OF THE BRAIN. IT WAS REPORTED THAT THE TRANSIENT ISCHEMIC ATTACK WAS NOT ION RELATED, BUT DUE TO ANESTHESIA. THE LESION SIZE WAS 0.7CM AND WAS LOCATED IN THE RIGHT LOWER LUNG - POSTERIOR SEGMENT. INSTRUMENTS UTILIZED DURING THE BIOPSY INCLUDED A 21G FLEXISION NEEDLE AND COMPATIBLE FORCEPS. THE IMAGING MODALITIES USED WERE CONE BEAM AND RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS). THE DIAGNOSIS FROM RAPID ON-SITE EVALUATION WAS AN ADENOCARCINOMA (MALIGNANT). THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. INTUITIVE SURGICAL INC., (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. HOWEVER, THERE WAS NO RESPONSE RECEIVED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155693 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ION ENDOLUMINAL SYSTEM