BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 13369643 · Received January 27, 2022

    Report

    Report Number
    2955842-2022-10127
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    December 2, 2021
    Report Date
    January 2, 2022
    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
    IL, US
    Reporter Occupation
    003

    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. ACCORDING TO AN ISI SENIOR FAILURE ANALYSIS ENGINEER, THE SYSTEM LOGS FOR SYSTEM EN0095 ON THE DATE OF THIS PROCEDURE ARE NOT AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT AN ION PROCEDURE AND SUSTAINED A PNEUMOTHORAX WHICH REQUIRED A CHEST TUBE BE PLACED AND THE PATIENT BE HOSPITALIZED FOR RECOVERY. THE CAUSE OF THE POST-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 A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED A PNEUMOTHORAX. THE SITE'S RADIAL PROBE WAS BROKEN WHEN THIS CASE WAS BEING PERFORMED, SO THE PHYSICIAN PERFORMED THE PROCEDURE USING THE ION VIRTUAL NAVIGATION PATHWAY AND FLUOROSCOPY. THE PHYSICIAN REPORTEDLY SAMPLED THE TARGET LESION MULTIPLE TIMES WITH A 21G FLEXISION BIOPSY NEEDLE. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE PHYSICIAN OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURALLY WITH A CHEST X-RAY. THE PHYSICIAN SAID THEY DO NOT BELIEVE THE ION SYSTEM CAUSED OR CONTRIBUTED TO THIS EVENT AND INDICATED: ¿IT¿S A KNOWN COMPLICATION OF ANY NAVI/TRANSBRONCHIAL BIOPSY.¿ THE PHYSICIAN REPORTED THAT THEY BELIEVE THIS PNEUMOTHORAX WOULD HAVE LIKELY OCCURRED VIA ANOTHER BIOPSY MODALITY AND THAT THERE WAS NO ION MALFUNCTION. THE PNEUMOTHORAX WAS MORE THAN 50% OF THE HEMITHORAX AND DID NOT GROW IN TIME AS THE PHYSICIAN INTERVENED WITH THE CHEST TUBE IMMEDIATELY. THE PATIENT EXPERIENCED MILD CHEST DISCOMFORT AND WAS NEVER CONSIDERED MEDICALLY UNSTABLE. THE PATIENT WAS HOSPITALIZED FOR ONE DAY AND WAS DISCHARGED AT A NORMAL BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84611 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-44 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown ION ENDOLUMINAL SYSTEM