BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 13315634 · Received January 21, 2022

    Report

    Report Number
    2955842-2022-10110
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    December 31, 2021
    Report Date
    December 31, 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
    IA, 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. PER AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, A POSTOPERATIVE X-RAY CONFIRMED A 3 CM PNEUMOTHORAX. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX AND THE PATIENT REQUIRED HOSPITALIZATION FOR THREE DAYS. AT THIS TIME, THE CAUSE OF THE POST-PROCEDURE 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. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURER.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF 31-DEC-2021 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER AND THE FOLLOWING WAS OBSERVED: THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND THE LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED A PNEUMOTHORAX. THE PHYSICIAN NAVIGATED TO THE LESION, CONFIRMED WITH RADIAL EBUS, AND THEN BEGAN THE BIOPSY WORKFLOW. THE BIOPSY WAS STARTED WITH A 21G NEEDLE AND THEN CHANGED TO BIOPSY FORCEPS. DURING THIS TIME, THE PHYSICIAN NOTICED DIVERGENCE BETWEEN THE LIVE CAMERA VIEW AND THE VIRTUAL NAVIGATION VIEW. A POSTOPERATIVE X-RAY CONFIRMED A 3 CM PNEUMOTHORAX. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX AND THE PATIENT REQUIRED HOSPITALIZATION FOR THREE DAYS. IT WAS NOTED THAT THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES. IT WAS BELIEVED BY THE PHYSICIAN THAT THE PNEUMOTHORAX OCCURRED DURING A BIOPSY OF THE PLEURA WHILE USING THE FORCEPS. THE PHYSICIAN DOES NOT BELIEVE THAT AN ION PRODUCT CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX.

    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
    610745 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-45 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ION ENDOLUMINAL SYSTEM