BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 13030818 · Received December 17, 2021

    Report

    Report Number
    2955842-2021-11772
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 18, 2021
    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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE ION PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT BECAME MEDICALLY UNSTABLE. AS A RESULT, THE PROCEDURE WAS ABORTED AND THE PATIENT'S VITAL SIGNS NORMALIZED. ALTHOUGH THE PHYSICIAN INDICATED THAT HE DOES NOT BELIEVE AN ION PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT, THE CAUSE OF THE PROCEDURE COMPLICATION 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 DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY BECAME HEMODYNAMICALLY UNSTABLE. ACCORDING TO THE PHYSICIAN, DURING THE EVENT, THE PATIENT BECAME HYPOXEMIC AND HYPOTENSIVE, WITH AN OXYGEN SATURATION LEVEL IN THE 70S (%). THE PROCEDURE WAS ABORTED, AND THE PATIENT'S VITAL SIGNS NORMALIZED SHORTLY AFTER EXTUBATION. THE PATIENT RETURNED TO BASELINE AND DID NOT REQUIRE HOSPITALIZATION AS A RESULT OF THE EVENT. THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES NOTED. THE PHYSICIAN DOES NOT BELIEVE THE ION PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925988 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female ION ENDOLUMINAL SYSTEM