BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 11953907 · Received June 8, 2021

    Report

    Report Number
    2955842-2021-10627
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 11, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP: ON (B)(6) 2021, INTUITIVE SURGICAL INC. (ISI) RECEIVED A RESPONSE TO AN EMAIL FROM THE CUSTOMER AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 AND DISCHARGED ON (B)(6) 2021. AFTER THE ION BIOPSY PROCEDURE THE PATIENT EXPERIENCED SHORTNESS OF BREATH, HYPOXEMIA AND A RIGHT SIDE PNEUMOTHORAX WITH TENSION PHYSIOLOGY. A 14FR CHEST TUBE WAS PLACED TO ASSIST IN THE PATIENT¿S RECOVERY FROM THE PNEUMOTHORAX. THE PNEUMOTHORAX WAS NOTICED TO BE RE-EXPANDING EVERY TIME THE CHEST TUBE WAS PLACED TO WATER SEAL. A PNEUMOSTAT WAS PLACED FOR THE PATIENT TO GO HOME ON DISCHARGE. THE PATIENT WAS GIVEN INSTRUCTIONS FOR CARING FOR THE PNEUMOSTAT AND WAS SENT HOME WITH VISITING NURSE ASSOCIATION SERVICES. THE PATIENT WAS ABLE TO AMBULATE WITHOUT SHORTNESS OF BREATH AFTER PLACEMENT.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE INTRA-PROCEDURE COMPLICATION CANNOT BE DETERMINED; ALTHOUGH 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. THE SYSTEM LOGS WERE PULLED FOR THE ION SYSTEM USED DURING PROCEDURE BY A SENIOR FAILURE ANALYSIS ENGINEER. HOWEVER, THE LOGS FOR SYSTEM EN0007 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 WAS PERFORMED AND THERE WERE NO ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT OR EVENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THE PATIENT EXPERIENCED AN ASYMPTOMATIC PNEUMOTHORAX FOLLOWING AN ION PROCEDURE WHICH WAS LARGER THAN FOUR CENTIMETERS IN SIZE AND REQUIRED A CHEST TUBE PLACEMENT TO RE-EXPAND THE LUNG. THE PATIENT WAS HOSPITALIZED FOR ONE DAY. FOLLOW-UP WAS PERFORMED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT EXPERIENCED A PNEUMOTHORAX 4.8CM IN SIZE. THE PATIENT REPORTEDLY REQUIRED A CHEST TUBE FOR LUNG RE-EXPANSION, AND WAS HOSPITALIZED FOR ONE DAY. THE SITE INDICATED THAT THIS COMPLICATION IS NOT RELATED TO PRE-EXISTING HEALTH CONDITIONS OR UNDERLYING PATIENT DISEASE. THE CUSTOMER SITE ALSO REPORTED THAT THIS COMPLICATION IS NEITHER RELATED TO THE ION SYSTEM, THE FLEXISION NEEDLE, NOR AN ION PRODUCT MALFUNCTION. THE PATIENT WAS STILL HOSPITALIZED AT THE TIME THE SITE REPORTED THIS EVENT. A CONTROL X-RAY WAS PERFORMED AFTER THE CHEST TUBE WAS PLACED AND SHOWED A "NEAR COMPLETE RESOLUTION OF PNEUMOTHORAX." THE DAY AFTER THE ION PROCEDURE, THE PATIENT WAS STILL HOSPITALIZED WITH A CHEST TUBE "AWAITING IMMINENT CLOSURE OF POST-PROCEDURE PNEUMOTHORAX." FOLLOW-UP: ON 20-MAY-2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CUSTOMER AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PNEUMOTHORAX. THE PHYSICIAN SAID THE PNEUMOTHORAX HAD NO RELATION TO THE ION SYSTEM OR FLEXISION BIOPSY NEEDLE AND THAT THE PROCEDURE WOULD HAVE HAD THE SAME RISK IF IT WAS PERFORMED WITH ANOTHER BIOPSY MODALITY OR WITH OTHER BIOPSY INSTRUMENTS. IT WAS REPORTED THAT THE PNEUMOTHORAX WAS LARGE WHEN INITIALLY SEEN ON THE CT AT LARGER THAN 4CM. IT WAS NOT CONFIRMED IF THE PNEUMOTHORAX EVER GREW IN SIZE. THE SURGEON REPORTED THAT THE PATIENT WAS ASYMPTOMATIC WITH LOW TO NORMAL O2 SATURATION AND WITH VITAL SIGNS WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857366 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-33 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ION ENDOLUMINAL SYSTEM