EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 (REF N3828922)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III BRONCHOVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus BF-Q190 bronchoscope has 69 adverse event reports, mostly describing the image cutting out or failing to display, communication errors, and in some cases heat-related damage or parts peeling or detaching. No deaths were reported; two reports involved injuries. Two recalls remain open: one began in September 2025 to clarify instructions for use with laser and electrosurgical equipment, and another over the scope getting stuck in an endotracheal tube connector. Reports fell from 17 in the previous 12 months to 2 in the most recent.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 04953170434792), received between Jun 14, 2023 and Mar 25, 2026 — classified as 2 injuries, 67 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (30 reports).
2 FDA recall records name this device's identifier, 2 still open.
8 other recalls cover devices cleared under the same FDA submission (K121959); 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.
Reports received per month
Recalls naming this device
- Sep 11, 2025Class IOpen, Classified
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Z-0063-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 27, 2023Class IIOpen, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2496-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image30
- Communication or Transmission Problem17
- Thermal Decomposition of Device7
- Detachment of Device or Device Component4
- Failure to Clean Adequately4
- Peeled/Delaminated4
- Poor Quality Image4
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions69
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXPERIENCED AN ERROR 216 AND B30 COMMUNICATION FAILURE. THE ISSUE OCCURRED DURING SETUP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24692055 ↗MalfunctionFeb 26, 2026Crack; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461250 ↗MalfunctionAug 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE DISPLAYED A DISTORTED IMAGE OUTSIDE OF CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874263 ↗MalfunctionAug 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THE BRONCHO VIDEOSCOPE EXHIBITED FORCEPS STUCK WITHIN THE FORCEPS CHANNEL DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22684131 ↗MalfunctionMay 9, 2025Corroded; No Display/Image; Corroded; No Display/Image
CORRECTION TO B5 FOR INFORMATION INADVERTENTLY LEFT OUT OF PREVIOUS REPORT: 'IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD AN OXIDIZED CONNECTOR BLOCK.'
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997981 ↗MalfunctionApr 23, 2025Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE SUBJECT DEVICE DISPLAYED A B30 (SCOPE COMMUNICATION ERROR). THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893891 ↗MalfunctionJan 15, 2025No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE IMAGE DISAPPEARED DURING ANGULATION IN THE UP/DOWN DIRECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21157290 ↗MalfunctionJan 3, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067085 ↗MalfunctionDec 3, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20836413 ↗MalfunctionDec 3, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835494 ↗MalfunctionNov 27, 2024Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793227 ↗MalfunctionNov 22, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD A B30 SCOPE COMMUNICATION ERROR. THE ISSUE OCCURRED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20765977 ↗MalfunctionNov 13, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677981 ↗MalfunctionNov 13, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD A BLURRY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677335 ↗MalfunctionNov 11, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED/MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20653915 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646515 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646476 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646379 ↗MalfunctionNov 5, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT NO IMAGE IS APPEARING ON THE BRONCHOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608232 ↗MalfunctionOct 29, 2024No Device Output; No Device Output
IT WAS REPORTED, THE BRONCHOVIDEOSCOPE SCREEN NO LONGER LIGHTS UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559418 ↗MalfunctionOct 24, 2024No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THAT THE BRONCHO VIDEOSCOPE DISPLAYED A B30 COMMUNICATION ERROR MESSAGE AND THE VIDEO DID NOT APPEAR ON THE MONITOR. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20523738 ↗MalfunctionOct 15, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE INSERTION TUBE COATING OF THE BRONCHOVIDEOSCOPE WAS PEELED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451557 ↗MalfunctionOct 1, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A PREPARATION FOR USE, THE BRONCHOVIDEOSCOPE ENTIRE SCREEN BECOMES BLACK AND SHOWS NO IMAGES (BLACKOUT). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20345119 ↗MalfunctionSep 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE BRONCHOVIDEOSCOPE PRODUCED A PERMANENT IMAGE INTERFERENCE AND NO IMAGE, OR A SNOWY IMAGE WAS VISIBLE. THE ISSUE OCCURRED DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20281205 ↗MalfunctionSep 17, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXPERIENCED AN IMAGE ISSUE. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20239839 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121959. One submission often covers many models, so check the product and lot details in each record.
- Z-0053-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
- Z-0049-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
- Z-0050-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
- Z-0060-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- Z-0192-2024 · Oct 12, 2023 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
- Z-0327-2024 · Sep 25, 2023 · Open, ClassifiedBronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190
- Z-2015-2023 · Jun 8, 2023 · Open, ClassifiedOlympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
- Z-2017-2023 · Jun 8, 2023 · Open, ClassifiedOlympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Other Bronchoscope (Flexible Or Rigid) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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