BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM

    MDR report key: 21608669 · Received March 14, 2025

    Report

    Report Number
    3021325287-2025-00004
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    November 21, 2024
    Report Date
    March 14, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    UDI-DI
    00850048825048
    PMA / PMN Number
    K223144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM, SCOPE AND WIRED CONTROLLER MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. FAILURE ANALYSIS PERFORMED SHOWS THAT THE FAILURE MODE IS LIKELY TO PUSH THE POTENTIOMETER INTO A NON-ZERO POSITION AT REST AND IS THEREFORE LIKELY TO CAUSE UNINTENDED MOTION. ALTHOUGH THIS IS NOT WHAT OCCURRED DURING THE CASE. REVIEW OF THE LOGS INDICATE THAT WHEN THE JOYSTICK BROKE, THE READING WAS BELOW THE DEAD ZONE AND THUS NO COMMAND TO MOVE WAS ISSUED. WHEN THE WIRED CONTROLLER WAS SHIPPED BACK TO NOAH MEDICAL, THE JOYSTICK POSITION WAS SHIFTED, RESULTING IN A HIGHER READING THAN WHEN THE FAILURE OCCURRED. NO OTHER MALFUNCTIONS WERE REPORTED. THE COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: DURING A GALAXY-ASSISTED BIOPSY PROCEDURE, THE LEFT THUMB JOYSTICK OF CONTROLLER (B)(6) BROKE LEADING TO A REPLACEMENT. THERE WERE NO INJURIES REPORTED OR TREATMENT ADMINISTERED. THIS COMPLAINT IS REPORTED DUE TO THE 2-YEAR REPORTABILITY RULE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A GALAXY-ASSISTED BIOPSY OF A LESION LOCATED IN THE RIGHT UPPER LOBE, THE CONTROLLER (B)(6) LEFT THUMB JOYSTICK BROKE. THE USER REPLACED THE CONTROLLER. THERE WERE NO INJURIES REPORTED OR TREATMENT ADMINISTERED. NO OTHER MALFUNCTIONS WERE REPORTED. ALTHOUGH THERE WERE NO INJURIES REPORTED, THE INVESTIGATION FINDINGS INDICATED THE POTENTIAL FOR UNINTENDED MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399098 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown