BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 15954402 · Received December 9, 2022

    Report

    Report Number
    2955842-2022-15808
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    May 5, 2022
    Report Date
    November 10, 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
    MI, 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 FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(6) 2022, PER AN ISI FAILURE ANALYSIS ENGINEER, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED DYNAMIC CHANGES ON THE EKG. IT IS UNKNOWN WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE COMPLICATION. IN ADDITION, THE CAUSE OF THE COMPLICATION IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED UNSPECIFIED DYNAMIC CHANGES ON THE EKG [ELECTROCARDIOGRAM]. THE TARGET NODULE WAS 3.1 CENTIMETERS AND ON THE LEFT LOWER LOBE. IT IS UNKNOWN IF THE SURGEON BELIEVES AN ION PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATION. IT IS ALSO UNKNOWN IF THE PATIENT REQUIRED UNPLANNED MEDICAL INTERVENTION AS A RESULT OF THE COMPLICATION. THE ION ENDOLUMINAL LUNG BIOPSY PROCEDURE WAS REPORTEDLY COMPLETED. HOWEVER, THE PATIENT¿S STATUS IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2910335 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown ION ENDOLUMINAL SYSTEM.