BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM

    MDR report key: 20700759 · Received November 15, 2024

    Report

    Report Number
    3021325287-2024-00014
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 15, 2024
    Manufacturer
    NOAH MEDICAL INC.
    Product Code
    EOQ
    UDI-DI
    00850048825048
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS INVESTIGATION OF THE WIRED CONTROLLER WAS PERFORMED. PHYSICAL INSPECTION OF THE CONTROLLER REVEALED THAT THERE WERE NO SIGNS OF MECHANICAL DAMAGE OR JOYSTICK MISALIGNMENT, ALL BUTTONS WERE FUNCTIONING AS EXPECTED WITH NO ISSUES OBSERVED. IT IS UNLIKELY TO BE THE CAUSE OF THE UNINTENDED MOTION OBSERVED IN THE CASE. SYSTEM LOGS WERE REVIEWED AND REVEALED THAT THE SCOPE WAS IN A BUCKLED CONFIGURATION AND HAD DIFFICULTY NAVIGATING DIFFICULT AIRWAYS AND UNBUCKLED WHILE ATTEMPTING TO MOVE PAST THE MAX INSERTION LIMIT. THIS CAUSED THE TIP TO MOVE CLOSER TO THE PATH LESION. BASED ON THE EVIDENCE OF SCOPE BUCKLING, THE CONTROLLER USED IN THE CASE IS FUNCTIONING AS EXPECTED. VIDEO LOGS WERE REVIEWED AND SHOWED NO USER ERRORS. THE COMPLAINT IS REPORTED DUE TO THE FOLLOWING FINDINGS: THE PNEUMOTHORAX WAS NOTICED DURING A GALAXY SYSTEM BIOPSY PROCEDURE, IT DID NOT REQUIRE MEDICAL INTERVENTION, THE PHYSICIAN IS UNSURE WHAT CAUSED THE INJURY, AND A MALFUNCTION OF UNINTENDED MOTION OCCURRED IN THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A GALAXY-ASSISTED BIOPSY OF A LESION LOCATED AT THE LEFT UPPER LOBE, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE INJURY WAS CONFIRMED BY X-RAY AND DID NOT REQUIRE MEDICAL INTERVENTION. UNINTENDED MOTION WAS REPORTED WITH THIS CASE, AND INVESTIGATION FINDINGS SHOWED THE SCOPE WAS IN A BUCKLED STATE AND HAD DIFFICULTY NAVIGATING DIFFICULT AIRWAYS, THERE WAS NO UNINTENDED MOTION, THE CONTROLLER WAS FUNCTIONING AS EXPECTED PER PHYSICAL INVESTIGATION. THE PHYSICIAN IS UNSURE IF THE UNINTENDED MOTION OBSERVED CONTRIBUTED TO THE INJURY AND THE CAUSE OF THE INJURY IS UNKNOWN. THERE WAS NO MALFUNCTION BASED ON INVESTIGATION FINDINGS, BUT USE OF THE SCOPE MAY HAVE CONTRIBUTED TO THE INJURY. ATTEMPTS TO COLLECT PATIENT DEMOGRAPHIC INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307067 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL INC. N/A N/A 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown