BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 15386725 · Received September 8, 2022

    Report

    Report Number
    2955842-2022-13913
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    August 11, 2022
    Report Date
    August 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WAS 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. PER AN ISI SENIOR FAILURE ANALYSIS ENGINEER, AS OF (B)(6) 2022, A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE FOLLOWED BY A CONVENTIONAL BAL, THE PATIENT¿S HEART RATE SUDDENLY DROPPED REQUIRING CARDIOPULMONARY RESUSCITATION. THE PATIENT EXPERIENCED AN INTRAPROCEDURAL CARDIOVASCULAR EVENT, WHICH TRIGGERED A CODE BLUE. THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND ADMITTED FOR TWO DAYS TO THE ICU WHERE HE WAS TAKEN OFF THE VENTILATOR THE DAY AFTER THE PROCEDURE. THE PHYSICIAN WAS UNCLEAR ABOUT TOTAL HOSPITALIZATION PERIOD BUT CONFIRMED THAT THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PHYSICIAN SWITCHED TO A STANDARD BRONCHOSCOPE IN ORDER TO PERFORM A BRONCHOALVEOLAR LAVAGE (BAL), WHEN SUDDENLY THE PATIENT¿S HEART RATE DROPPED AND THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. THE EVENT TRIGGERED A CODE BLUE AND WAS REPORTED THAT THE STAFF SUCCESSFULLY RESUSCITATED THE PATIENT WHO REPORTEDLY STABILIZED OVER TIME. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE PHYSICIAN AND OBTAINED THE FOLLOWING INFORMATION: AT THE END OF THE BIOPSY PROCEDURE AND AFTER THE TISSUE BIOPSIES WERE COMPLETED, THE PHYSICIAN PERFORMED A BAL WITH ICED SALINE FOLLOWED BY COLLECTION OF THE LAVAGED FLUID SAMPLE. THE DIAGNOSTIC BRONCHOSCOPE WAS REMOVED AND SHORTLY THEREAFTER, THE ANESTHESIOLOGIST REPORTED THAT THE PATIENT¿S HEART RATE WAS DROPPING TO THE 40¿S, 30¿S, AND EVENTUALLY ENTIRELY LOST THE PULSE. A CARDIOLOGIST WAS CALLED TO HELP ASSESS THE SITUATION BEDSIDE. CPR WAS INITIATED AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED UNTIL THE HEART BEAT RETURNED AND A RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED. AN ANESTHESIOLOGIST PLACED A CENTRAL LINE FOR IV ACCESS AND INSERTED A HEART LINE FOR INVASIVE BLOOD PRESSURE MONITORING BEFORE THE PATIENT WAS TRANSPORTED TO THE ICE. THE PHYSICIAN CLARIFIED THAT THE PATIENT CODED AFTER THE ION SYSTEM WAS UNDOCKED AND REMOVED FROM THE PATIENT¿S ENDOTRACHEAL TUBE (ETT), WHICH ALSO FACILITATED CPR. THE PATIENT WAS ADMITTED TO THE ICU FOR TWO DAYS AND WAS TAKEN OFF THE VENTILATOR THE DAY AFTER THE PROCEDURE. AFTER THE PATIENT RECOVERED AND STABILIZED, AN ECHOCARDIOGRAM OF THE HEART WAS PERFORMED WHICH INDICATED SIGNS OF A FRESH CARDIOVASCULAR EVENT. THE TREATING PHYSICIAN BELIEVED THAT THE PATIENT HAD A ¿MINI HEART ATTACK¿ FOLLOWING THE BIOPSY PROCEDURE, ¿SOMETHING ANESTHESIA-RELATED," OR IT WAS ¿INDUCED FROM A VAGAL RESPONSE FROM USING THE COLD SALINE.¿ THE ION PRODUCT WAS NOT BELIEVED TO CAUSE OR CONTRIBUTE TO THE EVENT. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NOT RELATED TO THE CHOSEN BIOPSY MODALITY. THE PHYSICIAN WAS NOT SURE HOW LONG THE PATIENT WAS HOSPITALIZED AFTER THE ICU ADMISSION BUT CONFIRMED THAT THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2096776 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-45 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Male ION ENDOLUMINAL SYSTEM