BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 13864058 · Received March 23, 2022

    Report

    Report Number
    2955842-2022-10720
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    February 22, 2022
    Report Date
    February 22, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE SYSTEM LOGS WERE REVIEWED FOR THE ION SYSTEM EN0038 ON THE PROCEDURE DATE OF (B)(6) 2022 BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. 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 COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT BLEEDING OCCURRED DURING A BRONCHOSCOPY PROCEDURE AFTER AN ION SYSTEM WAS USED TO OBTAIN BIOPSIES. THE PHYSICIAN USED A BALLOON BLOCKER TO RESOLVE THE BLEEDING. THE CAUSE OF THE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING OF ABOUT 300CC'S DURING A BRONCHOALVEOLAR LAVAGE (BAL). THE PHYSICIAN USED 10CC'S OF SALINE WITH SUCTION TO STOP THE BLEEDING. THE PHYSICIAN SAID THE PROCEDURE WENT WELL PRIOR TO THIS BLEEDING EVENT. THE PHYSICIAN REPORTED THAT THEY BELIEVE THIS EVENT WAS CAUSED FROM THE PRESSURE OF THE BRONCHOALVEOLAR LAVAGE DISRUPTING A BLOOD VESSEL CAUSING IT TO BLEED. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE PHYSICIAN OF THIS CASE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PHYSICIAN SAID THE ION PORTION OF THE PROCEDURE WAS COMPLETED AS THEY OBTAINED THE BIOPSIES BEFORE THIS EVENT OCCURRED. THE LESION WAS IN THE RIGHT MIDDLE LOBE MEASURING 13X6 MILLIMETERS. A FLEXISION BIOPSY NEEDLE WAS USED FOR FIVE OR SIX PASSES, THEN A BRUSH AND A TRANSBRONCHIAL BIOPSY WERE PERFORMED. AT THE TIME THE BLEEDING OCCURRED, THE PHYSICIAN WAS USING A BAL WITH 10CC¿S OF SALINE. THE PHYSICIAN SAID THE ION SYSTEM AND PRODUCTS DID NOT CONTRIBUTE TO THIS EVENT OTHER THAN IT BEING IN THE SAME ANATOMICAL REGION BEFORE THIS EVENT OCCURRED. THE PHYSICIAN WAS USING THE BAL AND RECEIVED BLOOD WHEN REMOVING THE CATHETER. THE PHYSICIAN USED EPINEPHRINE AND SALINE, BUT ULTIMATELY USED A BALLOON BLOCKER IN THE LUNG. THE BLOCKER WAS USED UNTIL THE BLEEDING SPONTANEOUSLY STOPPED AFTER ABOUT 15 MINUTES. THE PATIENT LOST ABOUT 300CC¿S OF BLOOD DUE TO THIS EVENT. THE PHYSICIAN SAID THEY THINK THE BAL PULLED OFF A BLOOD CLOT AND CAUSED THIS BLEED. THE EBUS PORTION OF THIS PROCEDURE WAS NOT COMPLETED DUE TO THE DESCRIBED BLEEDING EVENT. THE PHYSICIAN CLARIFIED THAT THE ION PORTION OF THE PROCEDURE WAS COMPLETED, BUT THE OVERALL BRONCHOSCOPY WAS NOT COMPLETED. THE PATIENT WAS HOSPITALIZED AFTER THIS EVENT FOR OBSERVATION AND RECEIVED ONE UNIT OF BLOOD. THE PHYSICIAN REPORTED THAT THE PATIENT WAS STILL HOSPITALIZED 21 DAYS LATER BECAUSE THEY HAD A SEIZURE. THE PHYSICIAN CLARIFIED THAT THE PATIENT¿S SEIZURES WERE UNRELATED TO THE ION PROCEDURE AND OVERALL BRONCHOSCOPY BECAUSE THE PATIENT HAS A HISTORY OF SEIZURES. THE PHYSICIAN REPORTED THIS PATIENT HAS A HISTORY OF HEART FAILURE, A SEIZER DISORDER, COPD WITH OXYGEN, HEMATOMAS, A PAST SMOKER, AND WAS A POOR SUBSTRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562312 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ION ENDOLUMINAL SYSTEM