BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 18735729 · Received February 19, 2024

    Report

    Report Number
    3021325287-2024-00002
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    January 23, 2024
    Report Date
    November 19, 2024
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    UDI-DI
    00850048825048
    PMA / PMN Number
    K223144
    Removal / Correction Number
    94193
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, A PNEUMOTHORAX INCIDENT WAS REPORTED IN A PATIENT, LINKED TO THE SCOPE ARTICULATING WITHOUT INPUT FROM THE WIRED CONTROLLER. DURING A TILT SWEEP STEP PROCEDURE, THE PHYSICIAN, ATTEMPTING TO REALIGN WITH THE LESION TARGET, NOTED INACCURATE RESPONSES FROM THE CONTROLLER, CAUSING THE SCOPE TO TURN WITHOUT ANY COMMANDS. SUBSEQUENTLY, A MINOR PNEUMOTHORAX OCCURRED BUT RESOLVED SPONTANEOUSLY WITHOUT MEDICAL INTERVENTION, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. THE INITIAL INVESTIGATION INCLUDED A THOROUGH REVIEW OF THE MANUFACTURING BATCH RECORD FOR THE WIRED CONTROLLER UTILIZED IN THE PROCEDURE. STRICT ADHERENCE TO SPECIFICATIONS WAS CONFIRMED DURING THE DEVICE'S MANUFACTURING AND SHIPMENT PROCESSES. UNFORTUNATELY, THE SCOPE USED IN THE INCIDENT WAS DISCARDED BY THE HOSPITAL AND, THEREFORE, NOT AVAILABLE FOR EVALUATION BY NOAH MEDICAL. A PRIMARY INVESTIGATION WAS INITIATED BY NOAH MEDICAL STAFF ENGINEERS, FOCUSING ON THE WIRED CONTROLLER. PRELIMINARY FINDINGS FROM THE INVESTIGATION REVEALED THAT THE NEUTRAL VALUES WERE NOT WITHIN THE EXPECTED RANGE. ONCE ROOT CAUSE IS IDENTIFIED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS. IT IS ACKNOWLEDGED THAT THE POTENTIAL FOR A PNEUMOTHORAX IS AN INHERENT RISK ASSOCIATED WITH BRONCHOSCOPY PROCEDURES, AND THIS RISK IS DULY DOCUMENTED IN NOAH MEDICAL'S RISK FILE. ONGOING TRACKING AND TRENDING OF SUCH INCIDENTS WILL BE MAINTAINED TO FACILITATE CONTINUOUS IMPROVEMENT AND RISK MANAGEMENT STRATEGIES.

    Additional Manufacturer Narrative · 0

    ISSUING SUPPLEMENTAL 3500A FORM TO CAPTURE REVISION AND RESUBMISSION OF MDR REPORT NUMBER. NO CHANGE IN MANUFACTURER'S NARRATIVE. NOAH MEDICAL SUBMITTED AN INITIAL MDR(3021325287-2024-002) DATED 06FEB2024) FOR A PNEUMOTHORAX INCIDENT. IT WAS LINKED TO THE SCOPE ARTICULATING WITHOUT INPUT FROM THE WIRED CONTROLLER. AN INVESTIGATION WAS INITIATED BY NOAH MEDICAL STAFF ENGINEERS, FOCUSING ON THE WIRED CONTROLLER. PRELIMINARY FINDINGS FROM THE INVESTIGATION REVEALED THAT THE NEUTRAL CALIBRATION VALUES WERE NOT WITHIN THE EXPECTED RANGE. THIS SUBMISSION IS A SUPPLEMENTAL RESUBMISSION WITH THE RESULTS OF THE INVESTIGATION. FURTHER INVESTIGATION, INCLUDING PHYSICAL INSPECTION OF THE CONTROLLER FOUND THE ROOT CAUSE WAS ATTRIBUTED TO A VARIATION IN THE EXECUTION OF THE CALIBRATION PROCESS OF THE SELECT WIRED CONTROLLERS. THE CONTROLLER USED IN THE PROCEDURE (B)(6) WAS FOUND TO HAVE BEEN IN A CALIBRATED STATE SUCH THAT THE SYSTEM ARTICULATED AT FULL SPEED WHEN NO PERCEIVABLE COMMAND WAS GIVEN. PLEASE NOTE THAT THE SERIAL NUMBER ORIGINALLY REPORTED FOR TIS EVENT WAS (B)(6) IN ERROR. THE CORRECT SERIAL NUMBER IS (B)(6).

    Description of Event or Problem · 0

    DURING A BRONCHOSCOPY PROCEDURE ASSISTED BY THE NOAH MEDICAL GALAXY SYSTEM, A PATIENT EXPERIENCED A PNEUMOTHORAX . THE PNEUMOTHORAX, WAS MINOR AND DID NOT REQUIRE ANY INTERVENTION. UTILIZING THE NOAH MEDICAL GALAXY SYSTEM, THE PHYSICIAN WAS NAVIGATING TO A LESION IN THE LEFT UPPER LOBE (LUL). FOLLOWING THE COMPLETION OF THE TILT PROCEDURE, THE SCOPE UNEXPECTEDLY EXHIBITED MOTION WITHOUT ANY INPUT FROM THE PHYSICIAN. THIS UNINTENDED MOTION CAUSED THE SCOPE TO DEVIATE, ULTIMATELY RESULTING IN A PNEUMOTHORAX IN THE PATIENT, A FACT CONFIRMED BY THE VIDEO LOG. IT IS NOTEWORTHY THAT DESPITE THE PNEUMOTHORAX, THE INCIDENT DID NOT REQUIRE ANY MEDICAL INTERVENTION, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Description of Event or Problem · 0

    ISSUING SUPPLEMENTAL 3500A FORM TO CAPTURE REVISION AND RESUBMISSION OF MDR REPORT NUMBER SUPPLEMENTAL REPORT. NO CHANGE IN MANUFACTURER'S NARRATIVE NOAH MEDICAL SUBMITTED AN INITIAL MDR (3021325287-2024-002) DATED (B)(6)2024) FOR A PNEUMOTHORAX INCIDENT. IT WAS LINKED TO THE SCOPE ARTICULATING WITHOUT INPUT FROM THE WIRED CONTROLLER. AN INVESTIGATION WAS INITIATED BY NOAH MEDICAL STAFF ENGINEERS, FOCUSING ON THE WIRED CONTROLLER. PRELIMINARY FINDINGS FROM THE INVESTIGATION REVEALED THAT THE NEUTRAL CALIBRATION VALUES WERE NOT WITHIN THE EXPECTED RANGE. THIS SUBMISSION IS A SUPPLEMENTAL RESUBMISSION WITH THE RESULTS OF THE INVESTIGATION. FURTHER INVESTIGATION, INCLUDING PHYSICIAL INSPECTION OF THE CONTROLLER FOUND THE ROOT CAUSE WAS ATTRIBUTED TO A VARIATION IN THE EXECUTION OF THE CALIBRATION PROCESS OF THE SELECT WIRED CONTROLLERS. THE CONTROLLER USED IN THE PROCEDURE (B)(6) WAS FOUND TO HAVE BEEN IN A CALIBRATED STATE SUCH THAT THE SYSTEM ARTICULATED AT FULL SPEED WHEN NO PERCEIVABLE COMMAND WAS GIVEN. PLEASE NOTE THAT THE SERIAL NUMBER ORIGINALLY REPORTED FOR TIS EVENT WAS (B)(6) IN ERROR. THE CORRECT SERIAL NUMBER IS (B)(6). THE INITIAL SUBMISSION OF THE SUPPLEMENTAL REPORT WAS MADE ON MAY 21, 2024. A REVISED MDR SUPPLEMENTAL REPORT TO UPDATE THE REPORT NUMBER WAS SUBMITTED ON OCTOBER 28, 2024. THE THIRD ATTEMPT TO SUBMIT THE REPORT WAS MADE ON NOVEMBER 19, 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528614 GALAXY SYSTEM GALALXY SYSTEM EOQ NOAH MEDICAL CORP. 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| O