EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 (REF N3828822)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
3 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 scope used to look inside the airways. Its 332 reports mostly describe heat damage and loss of image or connection. The reports mention no deaths or injuries. 3 recalls are open, covering added instructions for laser and heating use, scopes getting stuck in breathing tube connectors and burning inside airways during laser procedures. Reports fell from 153 in the prior 12 months to 10 in the latest 12 months.
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
- 333
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 333 adverse event reports that list this exact device (DI 04953170434778), received between May 23, 2023 and Sep 30, 2026 — classified as 333 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (153 reports).
3 FDA recall records name this device's identifier, 3 still open.
7 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-0049-2026 · 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 ↗
- 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
- Thermal Decomposition of Device153
- Communication or Transmission Problem70
- No Display/Image68
- Failure to Clean Adequately18
- Melted7
- Peeled/Delaminated6
- Poor Quality Image6
- Corroded5
Patient problems
- No Clinical Signs, Symptoms or Conditions331
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 333 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951945 ↗MalfunctionAug 13, 2026No Display/Image
Patient problems: Insufficient Information
MAUDE report 50245174 ↗MalfunctionAug 7, 2026No Display/Image
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176297 ↗MalfunctionApr 16, 2026No Display/Image; Communication or Transmission Problem; Failure to Clean Adequately
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE AND AN ERROR APPEARED. THE EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899871 ↗MalfunctionApr 14, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED AN ERROR CODE E228, SCOPE ID DATA CORRUPTION ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872867 ↗MalfunctionApr 9, 2026Melted; Communication or Transmission Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832336 ↗MalfunctionMar 31, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE LIGHT GUIDE LENS HAD A CHIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743943 ↗MalfunctionMar 10, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A CHIPPED LIGHT LENS AND TERMINAL COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24558671 ↗MalfunctionMar 2, 2026Break
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THE LENS WERE CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481823 ↗MalfunctionFeb 19, 2026Corroded; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389518 ↗MalfunctionJan 23, 2026No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A B30 ERROR (SCOPE COMMUNICATION). THE EVENT OCCURRED DURING SET-UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164514 ↗MalfunctionOct 17, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE IMAGE HAD NOISE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327809 ↗MalfunctionOct 15, 2025Corroded; No Display/Image; Communication or Transmission Problem; Material Twisted/Bent; Corroded; No Display/Image; Communication or Transmission Problem; Material Twisted/Bent
IT WAS REPORTED THE BRONCHOVIDEOSCOPE DISPLAYED AN E216 COMMUNICATION ERROR MESSAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285593 ↗MalfunctionSep 11, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE DISPLAYED SCOPE COMMUNICATION ERROR E216 CONTACT OLYMPUS. 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 23025908 ↗MalfunctionAug 29, 2025Communication or Transmission Problem; Communication or Transmission Problem
THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928183 ↗MalfunctionJun 24, 2025Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22319374 ↗MalfunctionMar 19, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE SHOWED A B30 SCOPE COMMUNICATION ERROR DURING SET UP PRIOR TO CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646934 ↗MalfunctionJan 22, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208460 ↗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 HAD BURNED/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 20834316 ↗MalfunctionNov 22, 2024Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20765740 ↗MalfunctionNov 22, 2024No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD B30 SCOPE COMMUNICATION ERROR AND NO PICTURE. THE ISSUE OCCURRED DURING SETUP FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20764348 ↗MalfunctionNov 22, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE RECEIVED B30 COMMUNICATION ERROR WHEN CONNECTED TO TWO SEPARATE TOWERS. THE EVENT WAS OBSERVED DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759802 ↗MalfunctionNov 22, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD A B30 SCOPE COMMUNICATION ERROR. THE EVENT OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759341 ↗MalfunctionNov 22, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE 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 20758858 ↗MalfunctionNov 21, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE FLEX VIDEO SCOPE HAD EXHIBITED B30 ERROR THAT IS APPEARING INTERMITTINGLY DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20750863 ↗
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-0050-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
- 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-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
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-DPOlympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall332 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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