BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 15200675 · Received August 10, 2022

    Report

    Report Number
    2955842-2022-13393
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    July 12, 2022
    Report Date
    July 12, 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
    TX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE COMPLICATION CANNOT BE DETERMINED ALTHOUGH THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE REPORTED PNEUMOTHORAX WAS DUE TO UNDERLYING EMPHYSEMA, DIFFICULT PROCEDURE, AND PAST PNEUMONECTOMY. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). 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 OF PNEUMOTHORAX. NO IMAGE OR VIDEO OF THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, A PATIENT DEVELOPED A PNEUMOTHORAX AND WAS HOSPITALIZED. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX. THE CAUSE OF THE PNEUMOTHORAX 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 ENDOBRONCHIAL LUNG BIOPSY PROCEDURE AND REPORTEDLY EXPERIENCED A PNEUMOTHORAX, WHICH OCCURRED AFTER THE SECOND BIOPSY WAS TAKEN. THE PATIENT WAS HOSPITALIZED AND RECEIVED A CHEST TUBE TO HELP RECOVER FROM THE PNEUMOTHORAX. (B)(6) 2022. INTUITIVE SURGICAL INC. (ISI) RECEIVED EMAIL RESPONSE FROM THE PHYSICIAN AND OBTAINED THE FOLLOWING INFORMATION: THE PHYSICIAN CONFIRMED THAT HE BELIEVED PNEUMOTHORAX OCCURRED AFTER THE SECOND TRANSBRONCHIAL BIOPSY WAS TAKEN. THE PHYSICIAN ALSO STATED THAT PNEUMOTHORAX WAS CAUSED FROM UNDERLYING EMPHYSEMA, DIFFICULT PROCEDURE, AND PAST PNEUMONECTOMY. THE PHYSICIAN ALSO CONFIRMED THAT THE TRANSBRONCHIAL LUNG BIOPSY PROCEDURE WAS COMPLETED USING CONE BEAM CT SCAN, ION CATHETER AND PREVIEW PATH FEATURE. THE PNEUMOTHORAX WAS IDENTIFIED VIA CONE BEAM CT AND THE SIZE OF PNEUMOTHORAX WAS DESCRIBED AS SMALL, AND IT WAS MANAGED IMMEDIATELY WITH NO ISSUE REPORTED. THE PATIENT¿S HOSPITALIZATION IS STILL ONGOING, BUT THE PNEUMOTHORAX HAS ALREADY BEEN RESOLVED WITH NO AIR LEAK. THE PHYSICIAN FURTHER REPORTED THAT THEY ARE KEEPING THE PATIENT TO OBTAIN ANOTHER BIOPSY WHILE THE CHEST TUBE IS IN PLACE. THE PATIENT¿S STATUS WAS REPORTED AS ¿STABLE AND DOING WELL, NO ISSUES, JUST WAITING ANOTHER PROCEDURE. THE PHYSICIAN STATED THAT THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522515 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female ION ENDOLUMINAL SYSTEM