EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 (UDI 04953170335174)Recalls & reported problems
Olympus Medical Systems Corp. · BF-H190 EEIII HIGH DEF DIAGNOS IC BRONCH · Class 2
All models of EVIS EXERA III BRONCHOVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 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 scope used to look into the airways. Many of its 1,185 reports describe no image, poor image or communication failures, and some mention chipped parts. The reports include 1 death and 104 injuries. Four open recalls name this device, including burn risk during high-frequency treatment and possible contamination from wet channels. Reports rose from 180 in the previous 12 months to 311 in the last 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
- 1,214
- Deaths reported
- 1
- Injuries reported
- 103
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 1,214 adverse event reports that list this exact device (DI 04953170335174), received between Sep 18, 2018 and Sep 30, 2026 — classified as 1 death, 103 injuries, 1,110 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (411 reports).
4 FDA recall records name this device's identifier, 4 still open.
6 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-0053-2026 · Root cause: Device Design · Recall details · FDA record ↗
- 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/Image411
- Communication or Transmission Problem357
- Detachment of Device or Device Component60
- Peeled/Delaminated60
- Poor Quality Image58
- Microbial Contamination of Device49
- Device Reprocessing Problem39
- Display or Visual Feedback Problem34
Patient problems
- No Clinical Signs, Symptoms or Conditions1,108
- Bacterial Infection43
- Unspecified Infection23
- Fungal Infection19
- No Patient Involvement6
- No Known Impact Or Consequence To Patient4
- Respiratory Tract Infection4
- Viral Infection4
Recent adverse event reports
The 25 most recent of 1,214 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Erratic or Intermittent Display; Material Fragmentation; Communication or Transmission Problem
It was reported by the customer that the scope experienced a scope communication error E216. The issue was found during set up for an unspecified procedure. No harm reported
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945595 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
The customer reported that the bronchovideoscope had fibers in the channel during an unknown procedure. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942572 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
The customer reported B30 error displayed during inspection for use involving an Olympus bronchovideoscope. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934013 ↗MalfunctionSep 25, 2026No Display/Image
The customer returned the BRONCHOVIDEOSCOPE to the service center for a unspecified image issue. During the device analysis, the investigator indicated no image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900086 ↗MalfunctionSep 24, 2026Optical Distortion; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889029 ↗MalfunctionSep 24, 2026Image Display Error/Artifact
The customer reported a colored fuzzy screen during set-up involving an Olympus Bronchovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876975 ↗MalfunctionSep 24, 2026Environmental Particulates
The customer returned the bronchovideoscope for a separate issue. During the evaluation of the returned device, it was observed that the objective lens was dirty. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876908 ↗MalfunctionSep 24, 2026Communication or Transmission Problem; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876621 ↗MalfunctionSep 23, 2026Excessive Heating
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device it was observed, the distal end cover was burnt. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872425 ↗MalfunctionSep 23, 2026No Display/Image; Residue After Decontamination; Noise, Audible
The customer reported no image involving an Olympus BRONCHOVIDEOSCOPE. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869904 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
The customer returned the BronchoVideoscope for a separate issue. During the device analysis, it was observed that Distal end Plastic Cover is detached was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855837 ↗MalfunctionSep 22, 2026Poor Quality Image
The customer returned the BRONCHOVIDEOSCOPE to the service center for a separate issue. During the device analysis, the investigator indicated a partial image blackout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854015 ↗MalfunctionSep 22, 2026Break
The customer returned the bronchovideoscope for a separate issue. During the initial evaluation of the returned device, foreign material inside channel was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849702 ↗MalfunctionSep 21, 2026Erratic or Intermittent Display
It was reported the Bronchovideoscope exhibited visible lines when turned on/ off during use. The issue occurred during a Diagnostic, Bronchoscopy procedure. The procedure was completed with the same device. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842575 ↗MalfunctionSep 21, 2026Device Reprocessing Problem; Temperature Problem
It was reported the Bronchovideoscope exhibited a foreign object inside the scope. The issue occurred during reprocessing. There was no patient involvement. The device was returned to Olympus for inspection. During the device analysis, a burnt distal end plastic cover and foreign material inside the channel was found.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841375 ↗MalfunctionSep 18, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822872 ↗MalfunctionSep 18, 2026Material Fragmentation
The customer returned the BRONCHOVIDEOSCOPE to the service center for a separate issue. During the device analysis, the investigator indicated the distal end has a chip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817769 ↗MalfunctionSep 16, 2026Peeled/Delaminated
The customer returned the bronchofiberscope for a separate issue. During the initial evaluation of the returned device, the distal end cover had a chip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782608 ↗MalfunctionSep 15, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780312 ↗MalfunctionSep 15, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778223 ↗MalfunctionSep 15, 2026Thermal Decomposition of Device
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device it was observed, plastic distal end cover was burned. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773289 ↗MalfunctionSep 14, 2026Communication or Transmission Problem
The customer reported that the bronchovideoscope had error code B30 during inspection for use. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748190 ↗MalfunctionSep 11, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741153 ↗MalfunctionSep 10, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722049 ↗MalfunctionSep 10, 2026No Display/Image; Communication or Transmission Problem
It was reported the Bronchovideoscope exhibited error code B30. The issue occurred during inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717190 ↗
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-0063-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
- Z-0060-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- 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-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-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 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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