GALAXY SYSTEM
Report
- Report Number
- 3021325287-2023-00002
- Event Type
- Injury
- Date Received
- December 21, 2023
- Date of Event
- November 30, 2023
- Report Date
- July 29, 2025
- Manufacturer
- NOAH MEDICAL INC.
- Product Code
- EOQ
- UDI-DI
- 00850048825048
- PMA / PMN Number
- K223144
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON NOVEMBER 30, 2023, A PNEUMOTHORAX WAS REPORTED IN A PATIENT, PARTIALLY ATTRIBUTED TO A DELAY IN FLUOROSCOPY DURING A MEDICAL PROCEDURE. WHEN THE LIVE FLUOROSCOPY VIEW RESUMED ON THE GALAXY SYSTEM AFTER A SHORT DELAY, THE PHYSICIAN'S BIOPSY TOOL WAS VISIBLY EXTENDED PAST THE TARGET AND INTO THE PERIPHERY OF THE RIGHT UPPER LOBE (RUL). IT SHOULD BE NOTED THAT WHILE THE SCOPE WAS USED TO OBTAIN ACCESS FOR THE BIOPSY TOOL TO THE LESION, THE SCOPE TIP WAS POSITIONED APPROXIMATELY 11 MM AWAY FROM THE TARGET LESION. THE PROCEDURE INVOLVED THE USE OF NON-NOAH MEDICAL DEVICES FOR BIOPSY. THE FINAL ATTEMPT TO BIOPSY THE LESION RESULTED IN A PNEUMOTHORAX IN THE PATIENT. A CHEST TUBE WAS INSERTED IN THE PATIENT TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED THE NEXT DAY AND THE PATIENT WAS REPORTED AS DOING WELL AND WAS RELEASED FROM THE HOSPITAL. THE DELAYED FLUOROSCOPY ISSUE WAS CONFIRMED BY REVIEWING VIDEO LOGS. THE INVESTIGATION INITIALLY INVOLVED A REVIEW OF MANUFACTURING RECORDS FOR BOTH THE GALAXY SYSTEM AND BRONCHOSCOPE, WHICH INDICATED NO DEVIATIONS OR NON-CONFORMANCES CONTRIBUTING TO THIS ISSUE. THE DEVICE'S MANUFACTURING AND SHIPMENT ADHERED STRICTLY TO SPECIFICATIONS. NO MALFUNCTIONS WERE REPORTED FOR THE SCOPE AND NOAH MEDICAL DID NOT RECEIVE THE SCOPE FOR EVALUATION AS IT HAD BEEN DISPOSED OF AT THE HOSPITAL. NOAH MEDICAL WILL CONDUCT INVESTIGATIONS ON THE SYSTEM, AS IT WAS REPORTED THAT THE SYSTEM HAD A DELAY IN FLUOROSCOPY. 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.
ON (B)(6) 2023, A PNEUMOTHORAX WAS REPORTED IN A PATIENT, PARTIALLY ATTRIBUTED TO A DELAY IN FLUOROSCOPY DURING A MEDICAL PROCEDURE. WHEN THE LIVE FLUOROSCOPY VIEW RESUMED ON THE GALAXY SYSTEM AFTER A SHORT DELAY, THE PHYSICIAN'S BIOPSY TOOL WAS VISIBLY EXTENDED PAST THE TARGET AND INTO THE PERIPHERY OF THE RIGHT UPPER LOBE (RUL). IT SHOULD BE NOTED THAT WHILE THE SCOPE WAS USED TO OBTAIN ACCESS FOR THE BIOPSY TOOL TO THE LESION, THE SCOPE TIP WAS POSITIONED APPROXIMATELY 11 MM AWAY FROM THE TARGET LESION. THE PROCEDURE INVOLVED THE USE OF NON-NOAH MEDICAL DEVICES FOR BIOPSY. THE FINAL ATTEMPT TO BIOPSY THE LESION RESULTED IN A PNEUMOTHORAX IN THE PATIENT. A CHEST TUBE WAS INSERTED IN THE PATIENT TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED THE NEXT DAY AND THE PATIENT WAS REPORTED AS DOING WELL AND WAS RELEASED FROM THE HOSPITAL. THE DELAYED FLUOROSCOPY ISSUE WAS CONFIRMED BY REVIEWING VIDEO LOGS. THE INVESTIGATION INITIALLY INVOLVED A REVIEW OF MANUFACTURING RECORDS FOR BOTH THE GALAXY SYSTEM AND BRONCHOSCOPE, WHICH INDICATED NO DEVIATIONS OR NON-CONFORMANCES CONTRIBUTING TO THIS ISSUE. THE DEVICE'S MANUFACTURING AND SHIPMENT ADHERED STRICTLY TO SPECIFICATIONS. NO MALFUNCTIONS WERE REPORTED FOR THE SCOPE AND NOAH MEDICAL DID NOT RECEIVE THE SCOPE FOR EVALUATION AS IT HAD BEEN DISPOSED OF AT THE HOSPITAL. NOAH MEDICAL WILL CONDUCT INVESTIGATIONS ON THE SYSTEM, AS IT WAS REPORTED THAT THE SYSTEM HAD A DELAY IN FLUOROSCOPY. SUPPLEMENTAL UPDATE 1. UPDATE B1: ADDED DEVICE MALFUNCTION. UPDATE D3: EMAIL ADDRESS AND COMPANY ADDRESS. UPDATE G1: TITLE AND COMPANY ADDRESS. UPDATE H6: MEDICAL CODES. UPDATE H11: AN INVESTIGATION INVOLVING SYSTEM LOGS, CODE REVIEW, AND EVALUATION OF THE REPRODUCTION METHODS BY THE SOFTWARE ENGINEER CONFIRMED THAT THE ROOT CAUSE OF THE FLUORO LAG WAS IMPROPER HANDLING OF THE QUEUE USED TO COLLECT FLUORO FRAMES, ALONG WITH THE ABSENCE OF A MECHANISM TO REMOVE OUTDATED FRAMES. SUPPLEMENTAL UPDATE 2: B4: DATE OF REPORT. G6: FOLLOW UP REPORT NUMBER: 2. H11: AN INVESTIGATION INVOLVING SYSTEM LOGS, CODE REVIEW, AND EVALUATION OF THE REPRODUCTION METHODS BY THE SOFTWARE ENGINEER CONFIRMED THAT THE ROOT CAUSE OF THE FLUORO LAG WAS IMPROPER HANDLING OF THE QUEUE USED TO COLLECT FLUORO FRAMES, ALONG WITH THE ABSENCE OF A MECHANISM TO REMOVE OUTDATED FRAMES. THIS ISSUE MAY HAVE CONTRIBUTED TO THE REPORTED INJURY.
ON NOVEMBER 30, 2023, A PNEUMOTHORAX WAS REPORTED IN A PATIENT, PARTIALLY ATTRIBUTED TO A DELAY IN FLUOROSCOPY DURING A MEDICAL PROCEDURE. WHEN THE LIVE FLUOROSCOPY VIEW RESUMED ON THE GALAXY SYSTEM AFTER A SHORT DELAY, THE PHYSICIAN'S BIOPSY TOOL WAS VISIBLY EXTENDED PAST THE TARGET AND INTO THE PERIPHERY OF THE RIGHT UPPER LOBE (RUL). IT SHOULD BE NOTED THAT WHILE THE SCOPE WAS USED TO OBTAIN ACCESS FOR THE BIOPSY TOOL TO THE LESION, THE SCOPE TIP WAS POSITIONED APPROXIMATELY 11 MM AWAY FROM THE TARGET LESION. THE PROCEDURE INVOLVED THE USE OF NON-NOAH MEDICAL DEVICES FOR BIOPSY. THE FINAL ATTEMPT TO BIOPSY THE LESION RESULTED IN A PNEUMOTHORAX IN THE PATIENT. A CHEST TUBE WAS INSERTED IN THE PATIENT TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED THE NEXT DAY AND THE PATIENT WAS REPORTED AS DOING WELL AND WAS RELEASED FROM THE HOSPITAL. THE DELAYED FLUOROSCOPY ISSUE WAS CONFIRMED BY REVIEWING VIDEO LOGS. THE INVESTIGATION INITIALLY INVOLVED A REVIEW OF MANUFACTURING RECORDS FOR BOTH THE GALAXY SYSTEM AND BRONCHOSCOPE, WHICH INDICATED NO DEVIATIONS OR NON-CONFORMANCES CONTRIBUTING TO THIS ISSUE. THE DEVICE'S MANUFACTURING AND SHIPMENT ADHERED STRICTLY TO SPECIFICATIONS. NO MALFUNCTIONS WERE REPORTED FOR THE SCOPE AND NOAH MEDICAL DID NOT RECEIVE THE SCOPE FOR EVALUATION AS IT HAD BEEN DISPOSED OF AT THE HOSPITAL. NOAH MEDICAL WILL CONDUCT INVESTIGATIONS ON THE SYSTEM, AS IT WAS REPORTED THAT THE SYSTEM HAD A DELAY IN FLUOROSCOPY. SUPPLEMENTAL: UPDATE B1: ADDED DEVICE MALFUNCTION. UPDATE D3: EMAIL ADDRESS AND COMPANY ADDRESS. UPDATE G1: TITLE AND COMPANY ADDRESS. UPDATE H6: MEDICAL CODES. UPDATE H11: AN INVESTIGATION INVOLVING SYSTEM LOGS, CODE REVIEW, AND EVALUATION OF THE REPRODUCTION METHODS BY THE SOFTWARE ENGINEER CONFIRMED THAT THE ROOT CAUSE OF THE FLUORO LAG WAS IMPROPER HANDLING OF THE QUEUE USED TO COLLECT FLUORO FRAMES, ALONG WITH THE ABSENCE OF A MECHANISM TO REMOVE OUTDATED FRAMES.
IT WAS REPORTED THAT DURING A GALAXY- ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX IN RUL (RIGHT UPPER LOBE) THAT REQUIRED TREATMENT WITH A CHEST TUBE. USING NOAH MEDICAL GALAXY SYSTEM, THE PHYSICIAN NAVIGATED THROUGH RUL LESION TO COMPLETE THE LUNG BIOPSY USING NON NOAH MEDICAL BIOPSY TOOLS SUCH AS A BIOPSY NEEDLE AND/OR BIOPSY FORCEP. IT WAS REPORTED THAT THE EVENT OCCURED DURING THE LAST ATTEMPT TO BIOPSY AND THE PHYSICIANS TOOL WAS GOING INTO THE PERIPHERY OF LUNG, WHICH WAS OBSERVED ON FLUOROSCOPY IN THE PROCEDURE VIDEO. AT THE CONCLUSION OF THE CASE, 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 NEXT DAY AND IS DOING WELL.
IT WAS REPORTED THAT DURING A GALAXY- ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX IN RUL (RIGHT UPPER LOBE) THAT REQUIRED TREATMENT WITH A CHEST TUBE. USING NOAH MEDICAL GALAXY SYSTEM, THE PHYSICIAN NAVIGATED THROUGH RUL LESION TO COMPLETE THE LUNG BIOPSY USING NON NOAH MEDICAL BIOPSY TOOLS SUCH AS A BIOPSY NEEDLE AND/OR BIOPSY FORCEP. IT WAS REPORTED THAT THE EVENT OCCURED DURING THE LAST ATTEMPT TO BIOPSY AND THE PHYSICIANS TOOL WAS GOING INTO THE PERIPHERY OF LUNG, WHICH WAS OBSERVED ON FLUOROSCOPY IN THE PROCEDURE VIDEO. AT THE CONCLUSION OF THE CASE, 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 NEXT DAY AND IS DOING WELL.
IT WAS REPORTED THAT DURING A GALAXY- ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX IN RUL (RIGHT UPPER LOBE) THAT REQUIRED TREATMENT WITH A CHEST TUBE. USING NOAH MEDICAL GALAXY SYSTEM, THE PHYSICIAN NAVIGATED THROUGH RUL LESION TO COMPLETE THE LUNG BIOPSY USING NON-NOAH MEDICAL BIOPSY TOOLS SUCH AS A BIOPSY NEEDLE AND/OR BIOPSY FORCEP. IT WAS REPORTED THAT THE EVENT OCCURED DURING THE LAST ATTEMPT TO BIOPSY AND THE PHYSICIANS TOOL WAS GOING INTO THE PERIPHERY OF LUNG, WHICH WAS OBSERVED ON FLUOROSCOPY IN THE PROCEDURE VIDEO. AT THE CONCLUSION OF THE CASE, 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 NEXT DAY AND IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306192 | GALAXY SYSTEM | GALAXY SYSTEM | EOQ | NOAH MEDICAL INC. | N/A | N/A | 00850048825048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Hospitalization| R | BIOPSY NEEDLE| BIOPSY NEEDLE |