BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM BRONCHOSCOPE

    MDR report key: 17625389 · Received August 25, 2023

    Report

    Report Number
    3021325287-2023-00001
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    July 6, 2023
    Report Date
    August 2, 2023
    Manufacturer
    NOAH MEDICAL
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCOPE WAS NOT RETURNED FOR EVALUATION AND WAS DISPOSED OF AT THE HOSPITAL. TO INVESTIGATE THE ISSUE, THE PROCEDURE WAS REVIEWED TO DETERMINE POSSIBLE CAUSES OF THE PNEUMOTHORAX. BASED ON INFORMATION RECEIVED FOR THE EVENT AND REVIEW OF LOGS THE PHYSICIAN WAS IN A DIFFICULT AREA TO NAVIGATE WITHIN THE LUNG'S RIGHT UPPER LOBE (RUL). THE SCOPE COULD NOT FULLY REACH THE LESION SITE AND WAS APPROXIMATELY 44-59 MM FROM THE TARGET LESION. THE PROCEDURE INCLUDED NON-NOAH MEDICAL DEVICES AND THE LESION BIOPSY PROCEDURE INVOLVED 3 PASSES WITH A BIOPSY NEEDLE AND 2 PASSES WITH BIOPSY FORCEPS. AFTER NAVIGATION THROUGH THE RUL, THE PHYSICIAN WAS SUCCESSFULLY ABLE TO NAVIGATE TO THE LUNG'S LOWER LEFT LOBE (LLL) IN THIS SAME PROCEDURE WITHOUT CAUSING AN INJURY. INVESTIGATION INTO THE ISSUE ALSO INCLUDED A REVIEW OF THE LOT HISTORY RECORD WHICH FOUND NO DEVIATIONS OR NONCONFORMANCES IN THIS LOT. THE DEVICE WAS MANUFACTURED AND SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. THE PHYSICIAN DOES NOT BELIEVE THE GALAXY SYSTEM MALFUNCTIONED AND LED TO A PNEUMOTHORAX. THERE WAS NO ALLEGATION OF DEVICE FAILURE. BEFORE THE START OF THE CASE, THE PHYSICIAN STATED THAT THE PATIENT WAS AT HIGH RISK FOR PNEUMOTHORAX BASED ON THE PATIENT'S ANATOMY AND LESION LOCATION. THIS PNEUMOTHORAX APPEARS TO HAVE OCCURRED DUE TO THE PATIENT'S ANATOMY AND LESION LOCATION AND POSSIBLY BY OTHER DEVICES PRESENT DURING THE PROCEDURE SUCH AS THE BIOPSY NEEDLE AND/OR FORCEPS, WHICH ARE NOT MANUFACTURED BY NOAH MEDICAL, BUT COME INTO DIRECT CONTACT WITH LUNG TISSUE. HOWEVER, THE NOAH MEDICAL GALAXY SYSTEM WAS PRESENT AND IS USED TO NAVIGATE TO THE LESION DURING THE CASE AND CAN NOT BE FULLY RULED OUT AS CONTRIBUTING TO AND/OR CAUSING THE PNEUMOTHORAX. THE POTENTIAL FOR A PNEUMOTHORAX TO OCCUR IS A KNOWN INHERENT RISK WITH A BRONCHOSCOPY PROCEDURE AND IS DOCUMENTED WITHIN NOAH MEDICAL'S RISK FILE. THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A GALAXY BRONCHOSCOPY CASE THAT AN ELDERLY PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RUL (RIGHT UPPER LOBE) THAT REQUIRED TREATMENT WITH A CHEST TUBE. THERE WERE TWO TARGET LESIONS, ONE IN THE RUL (RIGHT UPPER LOBE) AND A SECOND TARGET IN THE LLL(LEFT LOWER LOBE). USING THE NOAH MEDICAL GALAXY SYSTEM, THE PHYSICIAN NAVIGATED THROUGH THE RUL LESION TO COMPLETED A LUNG BIOPSY USING NON NOAH MEDICAL DEVICES WHICH INCLUDED A BIOSPY NEEDLE AND BIOSPY FORCEPS. USING THE NOAH MEDICAL GALAXY SYSTEM, THE PHYSICIAN THEN NAVIGATED TO THE LLL AND COMPLETED A LUNG BIOPSY USING NON NOAH MEDICAL DEVICES WHICH INCLUDED A BIOSPY NEEDLE AND BIOSPY FORCEPS. AT THE CONCLUSION OF THE CASE, IT WAS NOTED THAT THE PATIENT DEVELOPED A PNEUMOTHORAX IN THE RUL. TO CONFIRM THE PNEUMOTHORAX, A CHEST X-RAY WAS PERFORMED. A CHEST-TUBE WAS PLACED AND THE PATIENT WAS ADMITTED FOR OBSERVATION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND LAST REPORTED WAS DOING WELL .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083763 GALAXY SYSTEM BRONCHOSCOPE BRONCHOSCOPE EOQ NOAH MEDICAL NA 2023040601

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Hospitalization| R BIOSPY FORCEP| BIOSPY NEEDLE