Bronchoscope 10000769Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850048825000), received between Feb 13, 2024 and Aug 3, 2026 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 41-year-old male patient underwent a Galaxy-assisted bronchoscopy procedure for a lesion in the left lower lobe. There was no allegation that a malfunction of the Galaxy System occurred. The procedure was completed, and a pneumothorax was identified following the procedure. A chest tube was placed. Attempts to gather additional patient demographics were unsuccessful.

  Patient problems: Pneumothorax

  MAUDE report 50108842 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A GALAXY-ASSISTED BIOPSY OF A LESION LOCATED AT THE RIGHT UPPER LOBE, THE PATIENT DEVELOPED PNEUMOTHORAX. THE INJURY WAS FOUND ON X-RAY. THE PATIENT WAS TREATED WITH A CHEST TUBE AND OVERNIGHT ADMISSION. THE PHYSICIAN STATES THE INJURY IS NOT A RESULT OF THE GALAXY SYSTEM, AND ATTRIBUTES THE INJURY TO THE BIOPSY OF LESION 1. NO MALFUNCTIONS WERE REPORTED. ALTHOUGH THERE WERE NO MALFUNCTIONS REPORTED, THE USE OF THE SCOPE MAY HAVE CONTRIBUTED TO THE INJURY.

  Patient problems: Pneumothorax

  MAUDE report 20799543 ↗
• InjuryNov 27, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT WHILE UNDERGOING A GALAXY-ASSISTED BIOPSY PROCEDURE OF A LESION, THE PATIENT DEVELOPED BRONCHIAL TEAR AND BLEEDING. THE INJURY REQUIRED TREATMENT OF FLEXIBLE BRONCHOSCOPE WEDGE, BALLOON TAMPONADE, CHEST TUBE, AND COLD SALINE IRRIGATION. THE PHYSICIAN ATTRIBUTES THE INJURY TO THE SCOPE, WHICH HE CLAIMS HAD AN ABERRANT SHAPE AND MOVEMENT WHICH LED TO THE INJURY. ATTEMPTS TO COLLECT PATIENT DEMOGRAPHIC INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Bronchial Hemorrhage; Laceration(s)

  MAUDE report 20797905 ↗
• InjuryNov 22, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHILE UNDERGOING A GALAXY-ASSISTED BIOPSY PROCEDURE OF A LESION AT THE RIGHT UPPER LOBE, THE PATIENT DEVELOPED BLEEDING. ICE COLD SALINE WAS ADMINISTERED, AND ADDITIONAL INTERVENTION WAS NOT NECESSARY. THE PHYSICIAN ATTRIBUTES THE INJURY TO THE SCOPE AND STATES IT EXHIBITED ABNORMAL SHAPES AND BEHAVIOR DURING THE PROCEDURE. INVESTIGATION DETERMINED THE SCOPE WAS PREMATURELY REMOVED FROM THE PATIENT. ATTEMPTS TO COLLECT PATIENT DEMOGRAPHIC INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20764537 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A PNEUMOTHORAX WAS REPORTED WHILE THE PATIENT WAS UNDERGOING A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A 21MM LLL LESION. THE PROCEDURE WAS COMPLETED, AND THE PNEUMOTHORAX OCCURRED AFTER THE CASE. A CHEST TUBE WAS PLACED, THE PATIENT WAS THEN ADMITTED AND DISCHARGED AFTER 24 HOURS IN GOOD CONDITION. THE INJURY WAS ATTRIBUTED TO THE INSTABILITY OF THE CATHETER BEING USED WHILE USING THE NOAH SCOPE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE CASE WAS REVIEWED, AND IT WAS FOUND THAT SCOPE STABILITY IS HIGHLY RELATED TO ANATOMY, SUCH AS AIRWAY SIZE AND TORTUOSITY. FOR THIS CASE, THE GALAXY SCOPE DID PERFORM AS INTENDED AND FUNCTIONED AS EXPECTED WITH NO IDENTIFIED USER ERRORS. ALTHOUGH INVESTIGATION FINDINGS CONCLUDED THAT THE INJURY WAS NOT CAUSED BY THE GALAXY SYSTEM, THE INVOLVEMENT OF THE GALAXY SYSTEM IN THIS CASE LED TO THE DECISION TO REPORT. THE INITIAL SUBMISSION WAS MADE (B)(6) 2024, ADDITIONAL ATTEMPT MADE 28OCT2024. SUPPORT FROM EMDR HELPDESK RECEIVED A RESUBMISSION REQUESTED.

  Patient problems: Pneumothorax

  MAUDE report 20730618 ↗
• InjuryNov 19, 2024Difficult to Fold, Unfold or Collapse; Poor Quality Image; Difficult to Fold, Unfold or Collapse; Poor Quality Image

  ON (B)(6) 2024, THE PATIENT WAS UNDERGOING A BIOPSY PROCEDURE FOR A 13 MM LESION IN THE LEFT UPPER LOBE WHEN A PNEUMOTHORAX WAS REPORTED DURING THE PROCEDURE. THE USE OF THE GALAXY WAS ABORTED AND THE PHYSICIAN PROCEEDED WITH A MANUAL APPROACH TO COMPLETE THE PROCEDURE. A CHEST TUBE WAS PLACED, THE PATIENT WAS ADMITTED FOR AN OVERNIGHT STAY AND DISCHARGED THE NEXT DAY IN GOOD CONDITION. INFORMATION PROVIDED SUGGESTS THAT THE USE OF THE GALAXY WAS NOT ABORTED DUE TO THE INJURY, BUT DUE TO THE LIMITATIONS OF THE CURRENT SCOPE WOULD NOT REACH THE AREA THE PHYSICIAN IS TARGETING. THE INJURY WAS ATTRIBUTED TO THE "SHOVEL TIP" DESIGN OF THE CATHETER WHILE USING THE SCOPE. DURING THE PROCEDURE, THEY ENCOUNTERED ISSUES WITH THE CAMERA GRAPHICS AND SCOPE TENSION. THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE PRODUCT WAS REVIEWED FOR THE CAMERA GRAPHICS ISSUE AND FOUND THAT THEY WERE WORKING AS INTENDED WITH NO NOTICEABLE DEFECTS. THE SCOPE TENSION ISSUE WAS ALSO INVESTIGATED AND INVESTIGATION CONCLUDED THAT THE SCOPE ARTICULATES AND RELAXES IN ALL DIRECTIONS, NO TENSION WARNINGS, AND NO HARDWARE DEFECTS FOUND. ALTHOUGH INVESTIGATION FINDINGS CONCLUDED THAT INJURY WAS NOT CAUSED BY THE GAL

  Patient problems: Pneumothorax

  MAUDE report 20730364 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A GALAXY ASSISTED BIOPSY OF A LESION LOCATED AT THE ANTERIOR, RIGHT UPPER LOBE, THE PATIENT DEVELOPED A STROKE. AS A RESULT OF THE COMPLICATION, THE PATIENT WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT AND STILL INTUBATED. THE STROKE WAS CONFIRMED VIA CT SCAN AND MRI IMAGING, CONFIRMED BY A NEUROLOGIST. THE PATIENT WAS STARTED ON TISSUE PLASMINOGEN ACTIVATOR AND WAS ADMITTED TO THE ICU. THE PATIENT WAS DISCHARGED TO THE REHABILITATION UNIT WITH LEFT SIDED PARALYSIS. INFORMATION TO GATHER THE EXACT DISCHARGE DATE WAS UNSUCCESSFUL. THE PHYSICIAN DOES NOT ATTRIBUTE THE INJURY TO THE GALAXY SYSTEM. BRIEF OCCURRENCE OF EM SIGNAL LOSS WAS REPORTED DURING NAVIGATION, WHILE THE USER CONTINUED WITH LIVE FLUOROSCOPY WITHOUT INTERRUPTION, AND NO INJURY WAS OBSERVED DURING THE TIME OF EM SIGNAL LOSS.

  Patient problems: Stroke/CVA

  MAUDE report 20700871 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS REPORTED IN THE PATIENT. ALTHOUGH THE PHYSICIAN NOTED EM SIGNAL LOSS DURING THE PROCEDURE, AN INVESTIGATION OF THE LOGS AND AN EVALUATION OF THE RETURNED DEVICE CONCLUDED THAT THE NOAH MEDICAL DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. HOWEVER, THE PHYSICIAN PARTIALLY ATTRIBUTED THE INJURY TO THE GALAXY SYSTEM.

  Patient problems: Pneumothorax

  MAUDE report 20140766 ↗
• DeathFeb 13, 2024Entrapment of Device; Difficult to Insert; Difficult to Remove; Entrapment of Device; Difficult to Insert; Difficult to Remove

  THIS SUPPLEMENTAL REPORT SERVES AS A FOLLOW- UP TO AN EVENT DOCUMENTED UNDER MDR 3021325287-2024-00001. AT THE TIME OF THE INITIAL MDR SUBMISSION, THE PATIENT WAS UNDER INTENSIVE CARE UNIT (ICU) SUPERVISION AND BEING MONITORED BY A PHYSICIAN. SHE RECOVERED ENOUGH TO BE MOVED FROM ICU TO STEP DOWN. SUBSEQUENTLY THE PATIENT PASSED AWAY DUE TO MEDICAL COMPLICATIONS ARISING FROM SEPTIC SHOCK SECONDARY TO PNEUMONIA AND RESPIRATORY FAILURE. NOAH MEDICAL BECAME AWARE OF THIS OUTCOME DURING THE FOLLOW-UP ON THE PATIENT'S HEATH CONDITION. ADDITIONALLY, THE ATTENDING PHYSICIAN DID NOT ATTRIBUTE THE PATIENT'S DEATH TO ANY USAGE OR MALFUNCTION OF THE NOAH GALAXY DEVICE, BUT RATHER TO HER PRE-EXISTING HEATH CONDITIONS. GALAXY SYSTEM WAS USED IN PROCEDURE AND MAY HAVE CONTRIBUTED TO THE INITIAL INJURY. THE INITIAL SUBMISSION OF THE SUPPLEMENTAL REPORT WAS MADE ON 11MARCH2024 . SUPPORT FROM EMDR HELPDESK REQUESTED RESUBMISSION. RESUBMITTING THE REPORT ON NOVEMBER 21, 2024.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pneumonia; Pneumothorax; Septic Shock

  MAUDE report 18699853 ↗