EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 (REF N3828722)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 EVIS EXERA III bronchoscope is a flexible camera used to look inside the airways. Its 239 reports mostly describe image failures, communication faults and damaged parts. The reports include no deaths and 6 injuries, and reports fell from 63 in the prior 12 months to 8 in the last 12 months. Both of the 2 recalls naming this device are open, covering the scope getting stuck in an endotracheal tube connector and burning inside the airway during laser use.
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
- 240
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 04953170434754), received between Apr 28, 2023 and Sep 14, 2026 — classified as 6 injuries, 234 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (88 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
- 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 ↗
- Jun 8, 2023Class IOpen, Classified
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Z-2017-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image88
- Communication or Transmission Problem61
- Thermal Decomposition of Device41
- Peeled/Delaminated16
- Microbial Contamination of Device14
- Failure to Clean Adequately9
- Poor Quality Image8
- Output Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions233
- Respiratory Tract Infection6
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 240 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Dent in Material; Material Split, Cut or Torn
The customer returned the BronchoVideoscope for a separate issue. During the device analysis, it was observed that distal end plastic cover is chipped and light guide lens is chipped was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762616 ↗MalfunctionJul 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085690 ↗MalfunctionApr 23, 2026Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE PROBE COVER WAS BURNT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972346 ↗MalfunctionApr 13, 2026Poor Quality Image
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A NOISY IMAGE OCCURS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858854 ↗MalfunctionApr 3, 2026Corroded
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A NON-OPERATIONAL LIGHT GUIDE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, OXIDIZATION AND CORROSION ON THE CONNECTOR BLOCK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775652 ↗MalfunctionApr 1, 2026Communication or Transmission Problem; Output Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A B30 COMMUNICATION ERROR DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758685 ↗MalfunctionApr 1, 2026Degraded
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF DEFECTS OF THE DISTAL END AND INSERTION TUBE DEFECTS. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, LIGHT GUIDE LENS IS CHIPPED AND OBJECTIVE LENS WITHOUT GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755250 ↗MalfunctionMar 23, 2026Poor Quality Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE HAD AN IMAGE WITH INTERFERENCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671435 ↗MalfunctionNov 24, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638582 ↗MalfunctionSep 16, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE BRONCHOVIDEOSCOPE, HAD A B30 ERROR. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063741 ↗MalfunctionSep 16, 2025Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063531 ↗MalfunctionAug 27, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A VIDEO DEFECT WITH ERROR CODES B30, E315, E216 (SCOPE COMMUNICATION) OCCUR DURING SET-UP, PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22907571 ↗MalfunctionJul 21, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED NO IMAGE AND ERROR B30(COMMUNICATION OR TRANSMISSION PROBLEM). THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22559401 ↗MalfunctionJul 10, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE WITH INTERFERENCE WHEN CONNECTING TO THE PROCESSOR, WITH THE FOLLOWING ERRORS DISPLAYED ERR216 (SCOPE COMMUNICATION ERROR) AND B30 (SCOPE COMMUNICATION ERROR). THE ISSUE OCCURRED DURING INSPECTION OF THE DEVICE FOR USE BEFORE PATIENT IN A ROOM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467250 ↗MalfunctionJul 3, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD AN ERROR CODE B30 (SCOPE COMMUNICATION ERROR) OCCUR AT INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394195 ↗MalfunctionMar 7, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A E315 INCOMPATIBLE ENDOSCOPE ERROR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547182 ↗MalfunctionMar 6, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE LIGHT GUIDE COVER AND THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 21538588 ↗MalfunctionFeb 24, 2025Melted; Melted
WHILE INSPECTING A RETURNED OLYMPUS BONCHO VIDEOSCOPE LOANER DEVICE, IT WAS DISCOVERED THAT THE DISTAL END PLASTIC COMPONENT AS WELL AS THE LIGHT GUIDE LENS WERE BOTH BURNED. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446017 ↗MalfunctionFeb 5, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE DID NOT PRESENT AN IMAGE. THE ISSUE WAS IDENTIFIED AFTER COMPLETION OF THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21314999 ↗MalfunctionFeb 4, 2025No Display/Image; Material Puncture/Hole; No Display/Image; Material Puncture/Hole
IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE, THERE WAS NO IMAGE ON THE BRONCHOVIDEOSCOPE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305558 ↗MalfunctionJan 27, 2025Material Deformation; Material Deformation
NO NEW INFORMATION PROVIDED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241747 ↗MalfunctionJan 15, 2025Contamination; Contamination
IT WAS REPORTED THAT DURING REPROCESSING, THE FLEX VIDEO SCOPE DEVICE SUCTION CHANNEL TESTED POSITIVE FOR 12 COLONY FORMING UNITS (CFUS) OF ASPERGILLUS SP, PSEUDOMONAS. A COLONY OF CLADOSPORIUM WAS IDENTIFIED IN THE CANAL SUCTION WITH 5-25 CFUS. A COLONY OF ROSEOMONAS SPP., STAPHYLOCOCCUS HOMINIS, MICROCOCCUS LUTEUS AND 1 MOULD COLONY WAS ALSO IDENTIFIED AT 5-25 CFUS. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21162586 ↗MalfunctionDec 27, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028420 ↗MalfunctionDec 26, 2024Dent in Material; Dent in Material
IT WAS REPORTED THAT DURING INSPECTION IT WAS FOUND THAT THE CHANNEL WAS DENTED. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21021071 ↗MalfunctionDec 26, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, AFTER A DIAGNOSTIC BRONCHOSCOPY, THE BRONCHOVIDEOSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF MICROCOCCUS LUTEUS. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21018784 ↗
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-0060-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- Z-0053-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
- Z-0063-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
- 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-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
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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