Monarch Bronchoscope MBR-000211-BRecalls & reported problems
Auris Health, Inc. · Monarch Bronchoscope · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B634MBR000211B0), received between Sep 7, 2022 and Jan 29, 2024 — classified as 2 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Deformation Due to Compressive Stress1
- Difficult to Remove1
- No Display/Image1
- Poor Quality Image1
Patient problems
- Pneumothorax2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG. A CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED. THE PHYSICIAN STATED THAT THE SCOPE APPEARED TO BE KINKED AND THE PHYSICIAN ELECTED TO ABORT THE CASE.
Patient problems: Pneumothorax
MAUDE report 18597523 ↗MalfunctionMar 8, 2023No Display/Image; Poor Quality Image; Difficult to Remove; No Display/Image; Poor Quality Image; Difficult to Remove
IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THERE WAS AN INTERMITTENT VIDEO FEED ISSUE WITH THE BRONCHOSCOPE PRODUCING SYSTEM ERROR CODES. USING THE FLUOROSCOPIC VIEW, THE PHYSICIAN REPORTED THE BRONCHOSCOPE APPEARED TO HAVE ¿BUCKLED BACK ON ITSELF.¿ THE PHYSICIAN TRIED DISCONNECTING THE SCOPE AND SHEATH FROM THE ROBOT ARM. INITIALLY, THE PHYSICIAN WAS UNABLE TO REMOVE THE SCOPE. THE PHYSICIAN LATER REPORTED THAT HE WAS ABLE TO REMOVE THE SCOPE FROM THE PATIENT. THE PHYSICIAN CHOSE TO ABORT THE DIAGNOSTIC PROCEDURE. THE PHYSICIAN REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504374 ↗InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING MONARCH BRONCHOSCOPY PROCEDURE PATIENT EXPERIENCED PNEUMOTHORAX. LESION IN THE LINGULA 1.7 X 9 CM. LESION WAS PERIPHERAL. CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED, AND RELEASED ON (B)(6) 2022. THE CASE WAS COMPLETED AND THE PHYSICIAN DID NOT ATTRIBUTE THE EVENT TO THE MONARCH SPECIFICALLY. OTHER INSTRUMENTS USED IN THIS CASE WERE THE ARCPOINT NEEDLE, OLYMPUS CYTOLOGY BRUSH, OLYMPUS MICRO BRUSH, AND OLYMPUS ENDOJAW DISPOSABLE BIOPSY FORCEPS.
Patient problems: Pneumothorax
MAUDE report 15370487 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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