BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 16591577 · Received March 22, 2023

    Report

    Report Number
    2955842-2023-11458
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    February 24, 2023
    Report Date
    March 2, 2023
    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
    NC, 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. THE PHYSICIAN STATED THAT THE LOCATION OF THE LESION WHICH WAS LYING CLOSE TO THE PLEURA LIKELY CONTRIBUTED TO THE PNEUMOTHORAX. 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. AS OF (B)(6) 2023, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE ONLY PARTIAL LOGS EXIST AND THEY DO NOT INCLUDE ERROR LOGS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING CHEST TUBE AND HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE LESION WAS 2.2 CM IN DIAMETER AND LOCATED IN THE LEFT LOWER LOBE - ANTEROMEDIAL SEGMENT. TOOLS USED WERE A 21G FLEXISION NEEDLE AND THIRD PARTY COMPATIBLE FORCEPS. A BRONCHOALVEOLAR LAVAGE WAS DONE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE PHYSICIAN AND OBTAINED THE FOLLOWING INFORMATION: THE DISTANCE OF THE LESION TO THE PLEURA WAS 0MM ALONG THE DOME OF THE DIAPHRAGM. THE PHYSICIAN BELIEVED THAT THE PNEUMOTHORAX OCCURRED BECAUSE THE NODULE WAS ALONG THE PLEURA ON THE DOME OF THE DIAPHRAGM WITH LOTS OF RESPIRATORY MOTION DURING PROCEDURE. THE PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURALLY. THE PATIENT PRESENTED TO CLINIC AFTER WAKING WITH LEFT-SIDED CHEST PAIN ABOUT 72 HOURS AFTER THE PROCEDURE. A CHEST X-RAY IN CLINIC IDENTIFIED A PNEUMOTHORAX. THE INITIAL SIZE OF THE PNEUMOTHORAX WAS MODERATE AND IT DID NOT INCREASE OVER TIME. AN 8 FRENCH CHEST TUBE SIZE WAS PLACED TO RESOLVE THE PNEUMOTHORAX. NO OTHER INTERVENTIONS WERE PROVIDED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A TOTAL OF 3 DAYS, THEN DISCHARGED HOME. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103324 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female ION ENDOLUMINAL SYSTEM