BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 12728935 · Received November 1, 2021

    Report

    Report Number
    2955842-2021-11411
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    August 17, 2021
    Report Date
    August 20, 2021
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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. 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. THE SYSTEM LOGS WERE REVIEWED FOR THE ION SYSTEM USED DURING THIS PROCEDURE (EN0062) BY AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER: NO RELEVANT ERRORS WERE OBSERVED IN THE LOGS. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX THAT REQUIRED A CHEST TUBE AND HOSPITALIZATION. THE PATIENT ALSO REPORTEDLY EXPERIENCED DYSPNEA, CHEST PAIN, AND HYPOXIA AS SYMPTOMS AND WAS CONSIDERED MEDICALLY UNSTABLE AT SOME POINT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. BLANK MDR FIELDS: THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. INFORMATION IS NOT AVAILABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED INITIALLY THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED A PNEUMOTHORAX WHICH REQUIRED OBSERVATION. IT WAS REPORTED THAT A 23G FLEXISION BIOPSY NEEDLE AND A FORCEPS INSTRUMENT WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE PHYSICIAN OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PNEUMOTHORAX WAS FIRST IDENTIFIED POST-PROCEDURALLY WITH A CHEST X-RAY. THE PHYSICIAN REPORTED THAT SHE IS NOT SURE IF AN ION PRODUCT CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX BECAUSE THE PATIENT HAD SEVERE UNDERLYING CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) WITH A COUGHING FIT AFTER THE BRONCHOSCOPY. THE PHYSICIAN REPORTED THAT SHE BELIEVES THIS EVENT WOULD HAVE LIKELY OCCURRED VIA ANOTHER BIOPSY MODALITY. THE PHYSICIAN REPORTED THAT THE PROCEDURE WAS COMPLETED WITH NO PRODUCT MALFUNCTIONS. THE PNEUMOTHORAX WAS REPORTEDLY 105MM AND DID NOT GROW IN SIZE BECAUSE A CHEST TUBE WAS PLACED FOR THE PURPOSE OF RESOLVING THE PNEUMOTHORAX. THE PATIENT EXPERIENCED DYSPNEA, CHEST PAIN, AND HYPOXIA AND WAS CONSIDERED MEDICALLY UNSTABLE AT SOME POINT. THIS PATIENT WAS HOSPITALIZED FOR TWO DAYS AND WAS LAST SEEN IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626803 ION SYSTEM CART EOQ 380748-44 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR ION ENDOLUMINAL SYSTEM.