BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 13206838 · Received January 10, 2022

    Report

    Report Number
    2955842-2022-10031
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    December 1, 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
    UT, 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. SYSTEM LOGS WERE REVIEWED FOR THE ION SYSTEM USED DURING THIS PROCEDURE BY AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER. HOWEVER, THE LOGS FOR SYSTEM (B)(4) ON THE DATE OF THIS PROCEDURE WERE NOT AVAILABLE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT AN ION PROCEDURE AND EXPERIENCED A PNEUMOTHORAX WHICH REQUIRED THE PATIENT BE HOSPITALIZED WITH A CHEST TUBE PLACED. THE CAUSE OF THE PROCEDURAL COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. BLANK MDR FIELDS: 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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A 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.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED A PNEUMOTHORAX. AS A RESULT, THE PATIENT RECEIVED A CHEST TUBE AND WAS HOSPITALIZED. ON (B)(6) 2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE PHYSICIAN OF THIS PROCEDURE AND ADDITION INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PHYSICIAN REPORTED THAT THEY DO NOT THINK THIS PNEUMOTHORAX WAS RELATED TO THE ION, BUT RATHER THINKS IT WAS RELATED TO THE LOCATION OF THE TARGET NODULE WHICH WAS REPORTEDLY CLOSE TO THE PERIPHERY OF THE LUNG AND TO THE FISSURE. THE PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURALLY VIA CHEST X-RAY. THE PHYSICIAN REPORTED THAT THEY BELIEVE THIS INJURY WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY AND THAT NO ION MALFUNCTION OCCURRED. THE ION PROCEDURE WAS COMPLETED PER THE PHYSICIAN. THE PHYSICIAN REPORTED THAT THE PNEUMOTHORAX WAS MODERATE IN SIZE AND THAT THEY DID NOT ASSESS IF IT EVER GREW IN SIZE. THE PATIENT REPORTEDLY EXPERIENCED CHEST PAIN DUE TO THIS EVENT BUT WAS NEVER CONSIDERED UNSTABLE. THE PATIENT WAS HOSPITALIZED FOR OVER 24 HOURS. THE PHYSICIAN REPORTED THAT THE PATIENT HAS HAD NO FURTHER ISSUES.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711985 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-45 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female ION ENDOLUMINAL SYSTEM.