EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 (UDI 04953170335181)Recalls & reported problems
Olympus Medical Systems Corp. · BF-1TH190 EEIII HD THERAPEUTIC BRONCH W · 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 camera used in the airways. The 1,477 reports most often describe a blank screen, communication failures, and heat damage. The reports list 5 deaths and 134 injuries, and 495 reports came in the last 12 months, compared with 258 in the 12 months before. Three open recalls cover fire risk during cautery, wet channels that could carry infection, and a connector fit problem.
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
- 1,557
- Deaths reported
- 5
- Injuries reported
- 134
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1,557 adverse event reports that list this exact device (DI 04953170335181), received between Jul 13, 2018 and Sep 30, 2026 — classified as 5 deaths, 134 injuries, 1,418 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (390 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
- Oct 12, 2023Class IOpen, Classified
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
Z-0192-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0327-2024 · Root cause: Under Investigation by firm · 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/Image390
- Communication or Transmission Problem339
- Detachment of Device or Device Component222
- Thermal Decomposition of Device142
- Poor Quality Image85
- Material Fragmentation70
- Melted65
- Peeled/Delaminated65
Patient problems
- No Clinical Signs, Symptoms or Conditions1,414
- Bacterial Infection24
- Fungal Infection21
- Unspecified Infection21
- Foreign Body In Patient15
- Respiratory Tract Infection14
- No Patient Involvement11
- Pneumothorax11
Recent adverse event reports
The 25 most recent of 1,557 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954735 ↗MalfunctionSep 30, 2026Poor Quality Image
The customer returned the Bronchovideoscope for another issue. During evaluation of the device, it was noted that the image was intermittent. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949401 ↗MalfunctionSep 30, 2026Melted
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that there was a burn on the C-cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945746 ↗MalfunctionSep 30, 2026Image Display Error/Artifact
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that a damaged pixel and abnormal noise was found in the image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945305 ↗MalfunctionSep 29, 2026No Display/Image; Communication or Transmission Problem
The customer reported no image is showing video, involving an Olympus bronchovideoscope. The issue was found during preparation for use and before the patient was in the room. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937401 ↗MalfunctionSep 29, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935683 ↗MalfunctionSep 29, 2026No Display/Image; Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935350 ↗MalfunctionSep 29, 2026Melted
The customer reported there was a possible burnt distal tip or something burnt on the distal tip. The issue involved an Olympus Bronchovideoscope. Additionally, during the initial device analysis, the Olympus Service Repair Technician indicated that the Distal End Plastic Cover and one Light Guide Lens was burnt. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931685 ↗MalfunctionSep 28, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926009 ↗MalfunctionSep 28, 2026Material Fragmentation
The customer returned the videoscope to the service center for evaluation of a separate issue. During the evaluation, a reportable malfunction was identified: the distal end plastic was chipped. The affected component required replacement. No patient involvement was associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916467 ↗MalfunctionSep 28, 2026Communication or Transmission Problem
The customer returned the bronchovideoscope to the service center for a separate issue. During the device analysis, it was indicated that error code B30 (scope communication error) occurred. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915569 ↗MalfunctionSep 28, 2026Material Fragmentation
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that the Distal End Plastic Cover was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914363 ↗MalfunctionSep 25, 2026Break; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904625 ↗MalfunctionSep 25, 2026Erratic or Intermittent Display
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that there was a flickering image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896371 ↗MalfunctionSep 24, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891880 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component; Positioning Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888953 ↗MalfunctionSep 24, 2026Corroded
The customer returned the BRONCHOVIDEOSCOPE to the service center for evaluation related to a separate issue. During testing, it was identified that the distal end cover was corroded. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884496 ↗MalfunctionSep 24, 2026No Display/Image
The customer reported there was a black video camera image during preparation for use and before the patient was in the procedure room. The issue involved an Olympus Bronchovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883090 ↗MalfunctionSep 23, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870590 ↗MalfunctionSep 23, 2026Material Fragmentation
The customer returned the Bronchovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that the plastic distal end cover was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870491 ↗MalfunctionSep 23, 2026Material Fragmentation
The customer returned the bronchovideoscope to the service center for a separate issue. During the device analysis, it was indicated that a chipped distal end plastic cover was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869876 ↗MalfunctionSep 23, 2026No Display/Image; Communication or Transmission Problem
The customer reported an unspecified scope communication error during preparation for use and before the patient was in the procedure room. The issue involved an Olympus Bronchovideoscope. Additionally, during the device analysis, the Olympus Service Repair Technician indicated that there was no image. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868034 ↗MalfunctionSep 23, 2026No Display/Image
The customer reported there was no picture just a black screen during preparation for use and before the patient was in the procedure room. The issue involved an Olympus Bronchovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867856 ↗MalfunctionSep 23, 2026No Display/Image; Communication or Transmission Problem
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that there was a no image and a scope communication error B30. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867717 ↗MalfunctionSep 22, 2026Thermal Decomposition of Device; Material Fragmentation
The customer returned the Bronchovideoscope to the service center for evaluation related to a separate issue. During testing, the Service Repair Technician identified that the distal end plastic cover was burned, and chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862465 ↗
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-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-0060-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- Z-0050-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
- Z-2017-2023 · Jun 8, 2023 · Open, ClassifiedOlympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
- 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-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
- 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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