BEUDAMED
    FDA Adverse Event Death Summary report: N

    GALAXY SYSTEM

    MDR report key: 21952271 · Received May 2, 2025

    Report

    Report Number
    3021325287-2025-00024
    Event Type
    Death
    Date Received
    May 2, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 2, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM AND BRONCHOSCOPE MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. FAILURE ANALYSIS OF THE SCOPE COULD NOT BE PERFORMED AS THE SCOPE WAS DISCARDED. VIDEO LOGS WERE REVIEWED AND NO USE ERRORS WERE IDENTIFIED. AT TIMESTAMP 22:21, A SUDDEN SCOPE DISCONNECTION AND DISENGAGEMENT OF THE CART BRAKES WERE NOTED, WHICH IS LIKELY DUE TO THE NEED TO ADDRESS THE PATIENT'S CONDITION. THE PHYSICIAN DOES NOT BELIEVE THE GALAXY SYSTEM CONTRIBUTED TO THE BRADYCARDIA AND OXYGEN DESATURATION, ATTRIBUTING IT INSTEAD TO THE BREATH HOLD DURING THE TOOL INSERTION IN THE LESION TILT. IT IS IMPORTANT TO NOTE THAT THE PATIENT HAD PRE-EXISTING VENTRICULAR ISSUES. WHILE PERFORMING BREATH HOLDS DURING BRONCHOSCOPY IS NOT INHERENTLY HIGH-RISK, IT MAY PRESENT POTENTIAL RISKS, SUCH AS DECREASED OXYGEN LEVELS, PARTICULARLY IN PATIENTS WITH UNDERLYING CARDIAC CONDITIONS, AS SEEN IN THIS CASE. 10 DAYS AFTER THE EVENT, NOAH MEDICAL WAS INFORMED THAT THE PATIENT EXPIRED 2 DAYS AFTER THE BRONCHOSCOPY PROCEDURE. THE PHYSICIAN ATTRIBUTED THE DEATH TO MULTIORGAN FAILURE. ADDITIONALLY, THE PATIENT HAD RIGHT VENTRICULAR DYSFUNCTION, ELEVATED POTASSIUM LEVELS AND MULTIPLE MYOCARDIAL INFARCTIONS THE NIGHT OF PASSING. THIS CASE IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT DEVELOPED BRADYCARDIA AND OXYGEN DESATURATION DURING A GALAXY-ASSISTED BIOPSY PROCEDURE THAT REQUIRED MEDICAL INTERVENTION TO STABILIZE THE VITAL SIGNS AND THE PATIENT WAS ADMITTED. 2 DAYS LATER, THE PATIENT PASSED AWAY. THE PHYSICIAN DID NOT ATTRIBUTE THE BRADYCARDIA AND OXYGEN DESATURATION TO THE GALAXY SYSTEM AND STATES IT IS DUE TO THE BREATH HOLD AND THE PHYSICIAN ATTRIBUTED THE DEATH TO MULTIORGAN FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED BRADYCARDIA AND OXYGEN DESATURATION DURING A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A RIGHT UPPER LOBE LESION. THE INJURY OCCURRED DURING THE CASE AND THE ROBOT WAS SAFELY UNDOCKED TO ADDRESS THE PATIENT. MEDICATIONS WERE ADMINISTERED TO RAISE THE PATIENT'S VITALS (NOT PROVIDED BY THE HOSPITAL STAFF) AND THE PATIENT WAS ADMITTED FOR OBSERVATION. TWO WEEKS LATER, NOAH MEDICAL WAS INFORMED THAT THE PATIENT PASSED AWAY 2 DAYS AFTER THE PROCEDURE. THERE WERE NO MALFUNCTIONS REPORTED. THE PHYSICIAN DOES NOT BELIEVE THE GALAXY SYSTEM CONTRIBUTED TO THE BRADYCARDIA AND OXYGEN DESATURATION, ATTRIBUTING IT INSTEAD TO THE BREATH HOLD DURING THE TOOL INSERTION IN THE LESION TILT. IT IS IMPORTANT TO NOTE THAT THE PATIENT HAD PRE-EXISTING VENTRICULAR ISSUES. NOAH MEDICAL WAS INFORMED THAT THE PATIENT EXPIRED 2 DAYS AFTER THE BRONCHOSCOPY PROCEDURE. THE PHYSICIAN ATTRIBUTED THE DEATH TO MULTIORGAN FAILURE. ADDITIONALLY, THE PATIENT HAD RIGHT VENTRICULAR DYSFUNCTION, ELEVATED POTASSIUM LEVELS AND MULTIPLE MYOCARDIAL INFARCTIONS THE NIGHT OF PASSING. ADDITIONAL INFORMATION WAS REQUESTED FROM THE HOSPITAL, A SUPPLEMENTAL WILL BE SUBMITTED IF THE INFORMATION IS ACQUIRED BY NOAH MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072325 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 2024102302

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| D