BEUDAMED
    FDA Adverse Event Death Summary report: N

    GALAXY SYSTEM

    MDR report key: 18699853 · Received February 13, 2024

    Report

    Report Number
    3021325287-2024-00001
    Event Type
    Death
    Date Received
    February 13, 2024
    Date of Event
    February 21, 2024
    Report Date
    November 21, 2024
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    UDI-DI
    00850048825000
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT SERVES AS A FOLLOW-UP TO AN EVENT DOCUMENTED UNDER MDR 3021325287-2004-00001. AT THE TIME OF THE INITIAL MDR SUBMISSION, THE PATIENT WAS UNDER INTENSIVE CARE UNIT (ICU) SUPERVISION AND BEING MONITORED BY A PHYSICIAN. SHE RECOVERED ENOUGH TO BE MOVED FROM ICU TO STEP DOWN. SUBSEQUENTLY THE PATIENT PASSED AWAY DUE TO MEDICAL COMPLICATIONS ARISING FROM SEPTIC SHOCK SECONDARY TO PNEUMONIA AND RESPIRATORY FAILURE. NOAH MEDICAL BECAME AWARE OF THIS OUTCOME ON 21FEB2024 DURING THE FOLLOW-UP ON THE PATIENT'S HEALTH CONDITION. IMPORTANTLY, THE ATTENDING PHYSICIAN DID NOT ATTRIBUTE THE PATIENT'S DEATH TO ANY USAGE OR MALFUNCTION OF THE NOAH GALAXY DEVICE, BUT RATHER TO HER PRE-EXISTING HEALTH CONDITIONS. GALAXY SYSTEM WAS USED IN PROCEDURE AND MAY HAVE CONTRIBUTED TO THE INITIAL INJURY.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, DURING A NOAH GALAXY ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT EXPERIENCED BLEEDING, CARDIAC ARREST, AND BILATERAL PNEUMOTHORACES. THE INCIDENT PROMPTED A THOROUGH INVESTIGATION TO UNDERSTAND THE ROOT CAUSES AND CONTRIBUTING FACTORS. UPON REVIEWING THE INFORMATION GATHERED FROM THE EVENT AND ANALYZING THE VIDEO LOG, IT WAS OBSERVED THAT THE PHYSICIAN ENCOUNTERED CHALLENGES IN NAVIGATING A DIFFICULT AREA WITHIN THE PATIENT'S UPPER LEFT LOBE(LUL). THE PHYSICIAN WAS UNABLE TO FULLY REACH THE INTENDED LESION LOCATION WITH THE BRONCHOSCOPE CONTRIBUTING TO SCOPE BUCKLING. THROUGHOUT THE PROCEDURE, THERE WERE SIX INSTANCES OF SCOPE BUCKLING ERROR NOTIFICATIONS. ULTIMATELY, THE REPEATED ATTEMPTS BY THE PHYSICIAN TO DRIVE THE SCOPE FORWARD AND CONTINUED ACKNOWLEDGEMENT OF THE SCOPE BUCKLING WORKFLOW INHIBITOR ERROR MESSAGE RESULTED IN THE CREATION OF A KINK IN THE BRONCHOSCOPE SHAFT EXHIBITING A FISHHOOK SHAPE, FURTHER COMPLICATING THE PROCEDURE. EXTRACTION OF THE BRONCHOSCOPE IN THE BUCKLED AND FISHHOOK SHAPE PROVED CHALLENGING, REQUIRING THE PHYSICIAN TO MANUALLY RELEASE THE BRONCHOSCOPE FROM THE ROBOT AND PUSH AND ROTATE UNTIL THE BRONCHOSCOPE TIP WAS ABLE TO PASS BACK THROUGH THE ENDOTRACHEAL TUBE AND BE REMOVED FROM THE PATIENT. THE RESULTS OF THE INVESTIGATION DETERMINED THAT THE ADVERSE EVENT OCCURRED DUE TO A USE ERROR WHERE MULTIPLE (SIX) ACKNOWLEDGMENTS OF SCOPE BUCKLING ERROR MESSAGES OCCURRED, BUT THE USER FAILED TO FOLLOW THE ON-SCREEN AND IFU INSTRUCTIONS TO UTILIZE FLUOROSCOPIC IMAGING TO CHECK THE SHAPE OF THE SCOPE. EACH TIME THE SYSTEM ERROR MESSAGE OCCURRED, THE USE OF FLUOROSCOPY WAS NOT UTILIZED TO CHECK THE CONDITION OF THE BRONCHOSCOPE OR THE CAUSE OF THE SCOPE BUCKLING, THE USER ACKNOWLEDGED THE WORKFLOW INHIBITOR MESSAGE AND PROCEEDED FORWARD WITH THE CASE WITHOUT FOLLOWING THE ON-SCREEN AND IFU INSTRUCTIONS RELATED TO SCOPE BUCKLING WARNINGS. BASED ON THE INVESTIGATION, SCOPE BUCKLING WAS NOT A RESULT OF DEVICE MALFUNCTION OR DEFECTIVE SCOPE. IT WAS THE REPEATED USE ERROR OF DISMISSING THE ERROR MESSAGE WITHOUT PERFORMING THE RECOMMENDED FLUOROSCOPY TO VERIFY THE SCOPE POSITION THAT CAUSED DAMAGE TO THE SCOPE AND ULTIMATELY CONTRIBUTED TO HARMING THE PATIENT. SPECIFICALLY, THE GALAXY IFU (10000752 REV. F) CONTAINS THE FOLLOWING WARNING: "DO NOT CONTINUE INSERTING THE SCOPE IF SCOPE BUCKLING IS DETECTED. CONTINUED INSERTION MAY RESULT IN PATIENT INJURY." THE ON-SCREEN ERROR MESSAGE (WHICH IS ALSO INCLUDED IN THE IFU ALERTS TABLE) CONTAINS THE FOLLOWING VERBIAGE: "SCOPE BUCKLING DETECTED. PLEASE RETRACT UNTIL SCOPE INSERTION IS RESPONSIVE TO CONTROLS, THEN TRY AGAIN. IF THIS PROBLEM PERSISTS, PLEASE TAKE A FLUORO IMAGE TO CHECK THE SHAPE OF THE SCOPE." A COMPREHENSIVE INVESTIGATION ALSO INCLUDED A REVIEW OF THE LOT HISTORY RECORD ASSOCIATED WITH THE MEDICAL DEVICE USED IN THE PROCEDURE. NOTABLY, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED FOR THIS LOT. THE DEVICE WAS MANUFACTURED AND SHIPPED IN STRICT ADHERENCE TO SPECIFICATIONS. BECAUSE OF THE COMPLICATIONS ARISING FROM THE PROCEDURE, THE PATIENT IS CURRENTLY HOSPITALIZED. THE MEDICAL TEAM IS ACTIVELY MONITORING AND ADDRESSING THE PATIENT'S CONDITION. PATIENT'S CONDITION WILL CONTINUE TO BE MONITORED UNTIL RELEASE FROM THE HOSPITAL AND WILL BE DOCUMENTED IN THE COMPLAINT RECORD.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT SERVES AS A FOLLOW- UP TO AN EVENT DOCUMENTED UNDER MDR 3021325287-2024-00001. AT THE TIME OF THE INITIAL MDR SUBMISSION, THE PATIENT WAS UNDER INTENSIVE CARE UNIT (ICU) SUPERVISION AND BEING MONITORED BY A PHYSICIAN. SHE RECOVERED ENOUGH TO BE MOVED FROM ICU TO STEP DOWN. SUBSEQUENTLY THE PATIENT PASSED AWAY DUE TO MEDICAL COMPLICATIONS ARISING FROM SEPTIC SHOCK SECONDARY TO PNEUMONIA AND RESPIRATORY FAILURE. NOAH MEDICAL BECAME AWARE OF THIS OUTCOME DURING THE FOLLOW-UP ON THE PATIENT'S HEATH CONDITION. ADDITIONALLY, THE ATTENDING PHYSICIAN DID NOT ATTRIBUTE THE PATIENT'S DEATH TO ANY USAGE OR MALFUNCTION OF THE NOAH GALAXY DEVICE, BUT RATHER TO HER PRE-EXISTING HEATH CONDITIONS. GALAXY SYSTEM WAS USED IN PROCEDURE AND MAY HAVE CONTRIBUTED TO THE INITIAL INJURY. THE INITIAL SUBMISSION OF THE SUPPLEMENTAL REPORT WAS MADE ON 11MARCH2024 . SUPPORT FROM EMDR HELPDESK REQUESTED RESUBMISSION. RESUBMITTING THE REPORT ON NOVEMBER 21, 2024.

    Description of Event or Problem · 0

    ON (B)(6) 2024, DURING A BRONCHOSCOPY PROCEDURE ASSISTED BY THE NOAH GALAXY SYSTEM, A PATIENT EXPERIENCED BLEEDING, CARDIAC ARREST, AND BILATERAL PNEUMOTHORACES. THE TARGET LESION WAS LOCATED IN THE RIGHT UPPER LOBE (RUL). THE PHYSICIAN ATTEMPTED TO NAVIGATE TO THE LESION USING THE NOAH MEDICAL GALAXY SYSTEM, THE PROCEDURE WAS IMPEDED DUE TO SCOPE BUCKLING, RESULTING IN A KINKED SCOPE THAT PROVED CHALLENGING TO REMOVE FROM THE PATIENT'S BODY. CONSEQUENTLY, THE PATIENT SUFFERED ADVERSE EVENTS. PRESENTLY, THE PATIENT REMAINS HOSPITALIZED AS A RESULT OF COMPLICATIONS ARISING FROM THE PROCEDURE. THE MEDICAL TEAM IS ACTIVELY MONITORING AND ADDRESSING THE PATIENT'S CONDITION. FOR ADDITIONAL DETAILS, PLEASE REFER TO MANUFACTURER'S NARRATIVE FOR INVESTIGATION AND ROOTCAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81084 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 2023110703 00850048825000

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death| H| R| O