Galaxy System GAL-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00850048825048), received between Dec 21, 2023 and Sep 29, 2026 — classified as 1 death, 25 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 reports).

5 FDA recall records name this device's identifier, 5 still open.

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.

Recalls naming this device

1. Sep 12, 2025Open, Classified

   Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

   Z-0598-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 28, 2024Open, Classified

   Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

   Z-0742-2025 · Root cause: Component change control · Recall details · FDA record ↗

3. Oct 25, 2024Open, Classified

   Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.

   Z-0679-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Oct 25, 2024Open, Classified

   Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.

   Z-0693-2025 · Root cause: Device Design · Recall details · FDA record ↗

5. Mar 9, 2024Open, Classified

   Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

   Z-1734-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938894 ↗
• InjuryAug 27, 2026Intermittent Communication Failure

  It was reported that during a Galaxy-assisted bronchoscopy procedure, the physician navigated to a 20 mm left upper lobe (LUL) lesion following registration and TiLT+ imaging. The physician performed two needle biopsy passes and one forceps biopsy pass, after which bronchial bleeding was observed. The physician treated the bleeding using a balloon and cold saline. After treatment of the bleeding, the physician prepared to obtain additional samples and resumed navigation. During navigation, an "Awaiting Camera Signal" message appeared, followed several seconds later by a Scope Attached During E-Stop alert. An additional alert was reportedly displayed but could not be recalled at the time of the initial complaint. The issue appeared to be scope-related, and the physician expressed concern that the issue could have had a greater clinical impact had it occurred while the bleeding was being managed. Due to this concern, the physician elected not to obtain additional samples. System Error Alert 10028 was subsequently displayed and could not be recovered. The Clinical Representative performed a hard shutdown, waited approximately five minutes, and restarted the system. No further issues w

  Patient problems: Bronchial Hemorrhage

  MAUDE report 50488376 ↗
• MalfunctionAug 25, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434339 ↗
• InjuryAug 14, 2026Use of Device Problem

  It was reported that the patient underwent a Galaxy-assisted biopsy procedure targeting a 13 mm left upper lobe lesion located superior to the fissure. The procedure was completed successfully, and no Galaxy System or bronchoscope malfunctions were observed or reported. A pneumothorax was identified on a post-procedure chest X-ray. A left chest tube was placed, and the patient was admitted. Attempts to gather additional patient demographics were unsuccessful.

  Patient problems: Pneumothorax

  MAUDE report 50245249 ↗
• MalfunctionJul 30, 2026Unintended Application Program Shut Down

  The physician initiated TiLT during a Galaxy-assisted bronchoscopy procedure, at which time the time count was present on the screen but the C-arm graphics were missing from the right side. A system error then occurred, and the system shut down. The physician was able to perform biopsies before the shutdown. The system was restarted, and the procedure was completed. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085687 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN 80-YEAR-OLD FEMALE UNDERWENT A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE TARGETING A LEFT LOWER LOBE LESION AND A LEFT UPPER LOBE LESION. THERE WAS NO ALLEGATION THAT A GALAXY SYSTEM MALFUNCTION OCCURRED. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO NAVIGATE TO THE LESION AND PARKED APPROXIMATELY 38 MM FROM THE TARGET PRIOR TO PERFORMING TILT. THE PATIENT HAD A PACEMAKER, WHICH RESULTED IN ARTIFACT ON THE TILT IMAGE; HOWEVER, THE LESION WAS IDENTIFIED AND MARKED. DURING BIOPSY ACTIVITY, THE PHYSICIAN USED A NEEDLE TO TUNNEL THROUGH THE AIRWAY TO ACCESS THE LESION BUT EXPERIENCED DIFFICULTY REACHING THE BLUE CIRCLE DUE TO NEEDLE DEFLECTION. THE PHYSICIAN THEN PROCEEDED TO TARGET A 10 MM LEFT UPPER LOBE LESION. THE PHYSICIAN WAS ABLE TO NAVIGATE TO THE LESION; HOWEVER, WHEN TILT WAS PERFORMED, THE LESION COULD NOT BE LOCATED, AND THE PHYSICIAN IDENTIFIED A PNEUMOTHORAX. THE BRONCHOSCOPE WAS BACKED OUT, AND THE CASE WAS COMPLETED. ULTRASOUND WAS BROUGHT IN TO CONFIRM THE PNEUMOTHORAX, AND A CHEST TUBE WAS INSERTED. ATTEMPTS TO COLLECT ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

  Patient problems: Pneumothorax

  MAUDE report 25616366 ↗
• MalfunctionMar 31, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE USER EXPERIENCED NON-COMMANDED RETRACTION OF THE BRONCHOSCOPE AFTER THE CONTROLLER WAS SET DOWN. WHILE THE PHYSICIAN STEPPED AWAY TO RETRIEVE A RADIAL PROBE, THE ARM CONNECTED TO THE SCOPE WAS OBSERVED TO BE ACTIVELY RETRACTING. AFTER RE-NAVIGATION TO THE LESION, A SECOND UNCOMMANDED RETRACTION OCCURRED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION FROM A NOAH REPRESENTATIVE CONFIRMED THAT THERE WERE NO SYSTEM ERRORS OR ALERTS ASSOCIATED WITH THE RETRACTION EVENTS. AT THE TIME, THE CONTROLLER WAS NOT IN USE AND WAS RESTING ON THE SYSTEM. THE SCOPE WAS OBSERVED TO MOVE FROM APPROXIMATELY 20 MM TO 48 MM FROM THE TARGET DURING THE EVENT. THE CONTROLLER WAS REPORTEDLY PLACED WITH THE BUTTONS FACING UPWARD, AND NO OBVIOUS STUCK BUTTONS OR OFF-NEUTRAL JOYSTICK POSITION WERE OBSERVED. PATIENT DEMOGRAPHICS WERE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749552 ↗
• InjuryMar 23, 2026Use of Device Problem

  IT WAS REPORTED THAT A MALE PATIENT OF UNKNOWN AGE UNDERWENT A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A PLEURAL-ADJACENT ANTERIOR LESION IN THE RIGHT LUNG (LESION INFORMATION IDENTIFIED DURING INVESTIGATION AND NOT PROVIDED IN THE INITIAL COMPLAINT). AN ALLEGATION OF INABILITY TO VISUALIZE THE LESION USING THE GALAXY SYSTEM WAS REPORTED. IT WAS REPORTED THAT A PNEUMOTHORAX OCCURRED TOWARD THE END OF THE PROCEDURE, WHICH REQUIRED PLACEMENT OF A CHEST TUBE. NO ADDITIONAL INTERVENTIONS WERE REPORTED. HOSPITAL STAFF INDICATED THAT THEY WERE UNABLE TO LOCATE THE LESION DESPITE MULTIPLE TROUBLESHOOTING ATTEMPTS. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

  Patient problems: Pneumothorax

  MAUDE report 24670557 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PNEUMOTHORAX WAS REPORTED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE. INITIAL TILT SWEEP SHOWED THAT THE PHYSICIAN INITIALLY ACHIEVED CLEAR VISUALIZATION OF THE LESION AND USED BREATH-HOLDS AND CONSERVATIVE TARGETING DUE TO THE LESION'S HIGH-RISK PLEURAL AND FISSURE-BASED LOCATION. AFTER SEVERAL BIOPSIES, THE SCOPE APPEARED MORE DISTAL THAN EXPECTED, LEADING TO WITHDRAWAL AND RE-NAVIGATION. SUBSEQUENT TILT SWEEPS SHOWED THE LESION APPEARING PROGRESSIVELY MORE PROXIMAL RELATIVE TO THE AF OVERLAY, RAISING CONCERN THAT THE LESION HAD SHIFTED. DESPITE PERFORMING FIVE TILT SWEEPS, INCLUDING ATTEMPTS TO ISOCENTER BASED ON THE PREOPERATIVE CT, THE LESION COULD NOT BE CONFIDENTLY RE-IDENTIFIED. FLUOROSCOPY WAS THEN USED TO ASSESS FOR COMPLICATIONS, CONFIRMING A PNEUMOTHORAX. FOLLOWING THIS FINDING, BIOPSY WAS DISCONTINUED AND THE TEAM PROCEEDED ONLY WITH EBUS. TOMO MOTION INTERFERENCE ERRORS WERE ALSO OBSERVED DURING THE SWEEPS, RESULTING IN ADJUSTMENTS TO C-ARM POSITION AND SWEEP LENGTH. ATTEMPTS TO GATHER PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

  Patient problems: Pneumothorax

  MAUDE report 23897336 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BLEEDING WAS REPORTED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE AND WAS FIRST OBSERVED FOLLOWING THE THIRD FORCEPS BIOPSY. THE GALAXY BRONCHOSCOPE WAS RETRACTED, AND A MANUAL SCOPE WAS INSERTED TO MANAGE THE BLEED. EPINEPHRINE AND SALINE WERE ADMINISTERED, AND SUCTION WAS PERFORMED. THE BLEEDING REPORTEDLY REQUIRED APPROXIMATELY 15 MINUTES TO CONTROL AND WAS CLASSIFIED BY THE PHYSICIAN AS A NASHVILLE GRADE 2 BLEED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED HOME AFTER A SHORT STAY IN THE PACU. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

  Patient problems: Upper Respiratory Tract Injury

  MAUDE report 23897334 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE AND WAS DISCHARGED HOME THE SAME DAY WITHOUT COMPLICATIONS. THREE DAYS LATER, THE PATIENT REPORTED WORSENING CHEST PAIN AND WAS INSTRUCTED TO PRESENT TO THE EMERGENCY DEPARTMENT, WHERE A SMALL RIGHT-SIDED PNEUMOTHORAX WAS IDENTIFIED. A CHEST TUBE WAS PLACED AND REMAINED IN PLACE FOR 48 HOURS. THE PATIENT WAS DISCHARGED HOME AFTER 72 HOURS AND REPORTED TO BE IN GOOD CONDITION. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

  Patient problems: Pneumothorax

  MAUDE report 23762316 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURE, AND A PIGTAIL CATHETER WAS INSERTED. THE PATIENT WAS ADMITTED FOR APPROXIMATELY ONE WEEK AND LATER RECOVERED. NO MALFUNCTIONS WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 23650084 ↗
• InjuryNov 10, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURE ON CHEST X-RAY. THE LESION WAS NOTED TO BE IN CLOSE PROXIMITY TO THE FISSURE/PLEURA. A CHEST TUBE WAS INSERTED AND THE PATIENT ADMITTED OVERNIGHT. A CAMERA FRAME RATE ERROR WAS REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 23513493 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED MULTIPLE POST-OPERATIVE SEIZURES AFTER AWAKENING FROM ANESTHESIA FOLLOWING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE. THE PATIENT WAS ADMITTED TO THE ICU AND RECOVERED WITHOUT COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE REPORTED.

  Patient problems: Convulsion/Seizure

  MAUDE report 23498995 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PNEUMOTHORAX WAS IDENTIFIED POST-GALAXY PROCEDURE, AND A CHEST TUBE WAS INSERTED. THE PATIENT HAD A VALVE PLACED PREVIOUSLY DUE TO SEVERE EMPHYSEMA, AND THE PHYSICIAN NOTED THAT IT WAS THE ANESTHESIOLOGIST WHO OPTED TO INSERT THE CHEST TUBE. REPORTED MALFUNCTIONS INCLUDED SCOPE BUCKLING, LOSS OF VIDEO, AND EM SIGNAL LOSS.

  Patient problems: Pneumothorax

  MAUDE report 23498907 ↗
• DeathAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE WAS PERFORMED ON A PATIENT WITH NO DEVICE-RELATED MALFUNCTIONS OBSERVED. THE PATIENT WAS DISCHARGED THE SAME DAY; HOWEVER, APPROXIMATELY THREE HOURS LATER, THE PATIENT RETURNED WITH RESPIRATORY DISTRESS, EXPERIENCED CARDIAC ARREST, AND WAS FOUND TO HAVE A PNEUMOTHORAX. THE PHYSICIAN DID NOT ATTRIBUTE THESE EVENTS TO THE USE OF THE GALAXY DEVICE. ON AUGUST 4, 2025, THE COMPANY REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD UNFORTUNATELY PASSED AWAY. THE PHYSICIAN ATTRIBUTED THE CAUSE OF DEATH TO BILATERAL PNEUMOTHORAX RESULTING FROM THE THYMECTOMY AND CONFIRMED THAT THE GALAXY DEVICE WAS NOT CONSIDERED A CONTRIBUTING FACTOR.

  Patient problems: Cardiac Arrest; Pneumothorax

  MAUDE report 22922563 ↗
• InjuryAug 7, 2025Image Display Error/Artifact; Image Display Error/Artifact

  THIS COMPLAINT INVOLVES A SERIOUS INJURY IN WHICH THE PATIENT REQUIRED THE INSERTION OF A CHEST TUBE AND SUBSEQUENT HOSPITAL ADMISSION TO PREVENT PERMANENT DAMAGE. THE PATIENT WAS DISCHARGED THE NEXT DAY IN GOOD CONDITION. THE INJURY OCCURRED DURING A BRONCHOSCOPY PROCEDURE USING THE GALAXY SYSTEM AND WAS ASSOCIATED WITH REPORTED EM SIGNAL LOSS AND AF MISALIGNMENT.

  Patient problems: Pneumothorax

  MAUDE report 22738853 ↗
• InjuryJul 29, 2025Use of Device Problem; Use of Device Problem

  DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX, WHICH WAS MANAGED BY THE PLACEMENT OF A CHEST TUBE. A DEVICE MALFUNCTION OCCURRED DURING THE PROCEDURE, WHERE THE USER WAS INITIALLY UNABLE TO OBTAIN A RADIAL VIEW DURING BREATH HOLDS. THE ISSUE WAS RESOLVED AFTER PERFORMING A RE-TILT, AND THEREFORE IS UNLIKELY TO HAVE CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX. THE PHYSICIAN DID NOT ATTRIBUTE THE INJURY TO THE USE OF THE GALAXY SYSTEM, BUT RATHER TO THE BIOPSY PROCEDURE ITSELF. ATTEMPTS TO COLLECT PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

  Patient problems: Pneumothorax

  MAUDE report 22647079 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A GALAXY-ASSISTED BRONCHOSCOPY, THE PATIENT EXPERIENCED A PNEUMOTHORAX. IN RESPONSE, A CHEST TUBE WAS PLACED, AND THE PATIENT WAS DISCHARGED THE SAME DAY FOLLOWING ITS REMOVAL. THE PHYSICIAN REPORTED DIFFICULTY LOCATING THE LESION DURING THE PROCEDURE, INITIALLY SUSPECTED TO BE A DEVICE MALFUNCTION. HOWEVER, PRELIMINARY INVESTIGATION BY THE ENGINEER REVEALED THAT THE LESION WAS NOT VISIBLE ON THE CT SCAN ITSELF, WHICH ACCOUNTS FOR ITS ABSENCE ON TOMO. HOWEVER, THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO THE PNEUMOTHORAX. THE PHYSICIAN DOES NOT ATTRIBUTE THE INJURY TO THE USE OF THE NOAH MEDICAL DEVICE.

  Patient problems: Pneumothorax

  MAUDE report 22242395 ↗
• MalfunctionMar 14, 2025Break; Unintended Movement; Break; Unintended Movement

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608669 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A SMALL PNEUMOTHORAX. NO INTERVENTION WAS REQUIRED AS A RESULT OF THE PNEUMOTHORAX. DURING THE CASE, FLICKERING AUGMENTED FLUORO WAS OBSERVED AS A MALFUNCTION. HOWEVER, THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO THE INJURY. THE PNEUMOTHORAX OCCURRED DUE TO THE CRNA REMOVING THE PATIENT FROM BREATH HOLD AT THE MOMENT THE NEEDLE WAS DEPLOYED. THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE NOAH MEDICAL DEVICE BUT RATHER TO THE BREATH HOLD CHANGE.

  Patient problems: Pneumothorax

  MAUDE report 21537709 ↗
• MalfunctionFeb 20, 2025Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT AFTER A GALAXY-ASSISTED BIOPSY PROCEDURE, THE GALAXY SYSTEM DID NOT FULLY SHUT DOWN. THE SYSTEM WAS ABLE TO SHUT DOWN AFTER 15 MINUTES. THERE WERE NO INJURIES REPORTED OR TREATMENT ADMINISTERED WITH THIS CASE. NO OTHER MALFUNCTIONS WERE REPORTED.ALTHOUGH THERE WERE NO INJURIES REPORTED, THIS MALFUNCTION MAY CONTRIBUTE TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428239 ↗
• MalfunctionFeb 20, 2025Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT AFTER A GALAXY-ASSISTED BIOPSY PROCEDURE, THE GALAXY SYSTEM DID NOT FULLY SHUT DOWN. THE SYSTEM WAS ABLE TO SHUT DOWN AFTER A HARD SHUT DOWN. THERE WERE NO INJURIES REPORTED OR TREATMENT ADMINISTERED WITH THIS CASE. NO OTHER MALFUNCTIONS WERE REPORTED. ALTHOUGH THERE WERE NO INJURIES REPORTED, THIS MALFUNCTION MAY CONTRIBUTE TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21427859 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, FOLLOWING A GALAXY-ASSISTED PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE PACU, WHERE THE PHYSICIAN IDENTIFIED A PNEUMOTHORAX. AS A RESULT, THE PATIENT WAS HOSPITALIZED FOR OBSERVATION; HOWEVER, NO CHEST TUBE INTERVENTION WAS REQUIRED. THE PHYSICIAN DOES NOT ATTRIBUTE THE INJURY TO THE USE OF THE NOAH GALAXY DEVICE BUT INSTEAD CONSIDERS IT A COMPLICATION OF THE BIOPSY PROCEDURE. NO MALFUNCTIONS OR IRREGULARITIES WERE REPORTED WITH THE GALAXY DEVICE, WHICH FUNCTIONED AS EXPECTED THROUGHOUT THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21370348 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE IN JANUARY, FOLLOWING FORCEPS BIOPSIES, THE PHYSICIAN NOTICED A CLOT. WHILE ATTEMPTING TO REMOVE THE CLOT WITH FORCEPS, THE PHYSICIAN BRIEFLY EXPERIENCED A LOSS OF VISION DUE TO THE CLOT. THE PATIENT LATER EXPERIENCED BLEEDING. TO MANAGE THE BLEEDING, THE PHYSICIAN USED A FOGARTY BALLOON TO TAMPONADE FOR A FEW MINUTES, SPRAYED EPINEPHRINE THROUGH THE SCOPE, AND CLEANED BOTH LUNGS. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED IN THE PACU, WHERE THEY RECOVERED AND WERE LATER DISCHARGED. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE USE OF THE GALAXY DEVICE BUT RATHER TO THE BIOPSY PROCEDURE AND CLOT DISLODGEMENT. NO MALFUNCTIONS OF THE GALAXY DEVICE WERE REPORTED DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21369324 ↗