BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 13260545 · Received January 14, 2022

    Report

    Report Number
    2955842-2022-10071
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    December 15, 2021
    Report Date
    December 15, 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
    MO, 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. THE SYSTEM LOGS FOR THE EVENT DATE (B)(6) 2021 WERE NOT AVAILABLE AS OF THIS TIME OF THE REPORT, HENCE, NO LOG REVIEW FOR THIS PROCEDURE HAS BEEN PERFORMED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. AS A RESULT, AN ENDOBRONCHIAL BALLOON BLOCKER WAS USED TO RESOLVE THE BLEEDING. THE CAUSE OF THE INTRA-PROCEDURAL 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 DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, EXCESSIVE BLEEDING OCCURRED, WHICH REQUIRED AN ENDOBRONCHIAL BALLOON BLOCKER TO RESOLVE. THE CUSTOMER REPORTED THAT THIS OCCURRED WHEN THE FLEXISION BIOPSY NEEDLE HIT A CARINA. THE CUSTOMER REPORTED THAT THEY DO NOT BELIEVE THE FLEXISION BIOPSY NEEDLE WAS DEFECTIVE. THE PHYSICIAN USED A BRONCHOSCOPE TO REMOVE BLOOD WHILE THE BALLOON BLOCKER WAS USED TO STOP THE BLEEDING. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE PHYSICIAN TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626215 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male ION ENDOLUMINAL SYSTEM