Monarch Bronchoscope MBR-000211-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI B634MBR000211A0), received between Jul 7, 2022 and Mar 17, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K193534); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH PROCEDURE THE PHYSICIAN WAS UNABLE TO TURN THE BRONCHOSCOPE ON AFTER REMOVING THE SCOPE FROM THE PATIENT'S TRACHEA DUE TO THE CAMERA IMAGE BEING GRAINY AND ULTIMATELY GOING BLACK. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621388 ↗
• InjuryJan 9, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118483 ↗
• MalfunctionDec 29, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE PATIENT WAS ON THE TABLE UNDER ANESTHESIA PHYSICIAN EXPERIENCED EM SENSOR ERROR. THE PHYSICIAN ELECTED TO ABORT THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032403 ↗
• InjuryMar 18, 2024No Display/Image; No Display/Image

  THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921615 ↗
• InjuryMar 18, 2024No Display/Image; No Display/Image

  THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921604 ↗
• InjuryAug 25, 2023Device Damaged by Another Device; No Apparent Adverse Event; Device Damaged by Another Device; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY THE PHYSICIAN REMOVED A FOREIGN OBJECT WHILE WITHDRAWING THE SPECIMEN TISSUE FROM THE SPECIMEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17626992 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, A PNEUMOTHORAX AND PNEUMOMEDIASTINUM WERE NOTED POST-PROCEDURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PNEUMOTHORAX AND PNEUMOMEDIASTINUM RESOLVED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pneumothorax

  MAUDE report 17509786 ↗
• MalfunctionNov 16, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN EXPERIENCED A 1205-50-0-0 FAULT WHEN PRESSING THE ¿SET¿ DURING ROLL CORRECTION. THE PHYSICIAN REPOSITIONED THE FIELD GENERATOR, POWER CYCLED THE SYSTEM, AND SWITCHED TO A SECOND SCOPE, HOWEVER, THE ISSUE PERSISTED. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE AND RESCHEDULE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE SYSTEM FAULT CODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807348 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE FIRST, AND ONLY CASE OF THE DAY (1:45PM), THE RIGHT LOWER LOBE (RLL) LESION 1.5CM EXPECTED INFECTION, PHYSICIAN DID 4 BRUSHES AND PATIENT SUSTAINED A SMALL PNEUMOTHORAX. A CHEST TUBE WAS PLACED TAKING A WEEK TO RESOLVE. AURIS FORCEPS, A MICRO BRUSH (BRAND WAS NOT RECORDED), AND AN OLYMPUS PERIVIEW FLEX TBNA NEEDLE WERE ALL USED IN THIS CASE. PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE MONARCH SYSTEM.

  Patient problems: Pneumothorax

  MAUDE report 15370728 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE REMOVAL BRONCHOSCOPE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). IT WAS REPORTED THAT A HUGE SNAPPING AND STRAIGHTENING OF THE BRONCHOSCOPE OCCURRED DURING THE REMOVAL.

  Patient problems: Pneumothorax

  MAUDE report 15249489 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN NAVIGATED TO THE LESION, AND WHEN THE RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS INTRODUCED, IT PUSHED A SMALL WHITE FOREIGN BODY (FB) OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS ABLE TO REMOVE THE FB USING FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15230044 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A TEAR IN THE AIRWAY. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND DISCHARGED FOLLOWING DAY. THE PHYSICIAN NAVIGATED TO THE LESION IN PAIRED MODE. AT SOME POINT THE PHYSICIAN DROPPED THE SHEATH AND ADVANCED THE SCOPE ONLY. AT THE LESION, THE PHYSICIAN ADVANCED THE SHEATH ONLY TO PROVIDE MORE STABILITY WHILE INTRODUCING BIOPSY TOOLS. WHEN THE PHYSICIAN HAD COMPLETED AND RETRACTED BOTH THE SCOPE AND SHEATH THE PHYSICIAN NOTICED A TEAR IN THE AIRWAY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 14951435 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193534. One submission often covers many models, so check the product and lot details in each record.

• Z-1383-2026 · Jan 21, 2026 · Open, Classified
  MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
• Z-0448-2024 · Oct 18, 2023 · Open, Classified
  Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
• Z-0450-2024 · Oct 18, 2023 · Open, Classified
  Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
• Z-0449-2024 · Oct 18, 2023 · Open, Classified
  Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w