EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 (REF N4504020)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 for looking inside the airways. Of its 1,123 reports, 6 describe injuries and 1,117 malfunctions, with no deaths. Most describe no image or an erratic display, and poor image quality. 4 recalls, 3 open, cover a wet channel after repair that could lead to infection, a scope lodging in a breathing tube connector, and cleaning instructions.
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
- 1,146
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 1,146 adverse event reports that list this exact device (DI 04953170342134), received between Jul 13, 2018 and Sep 29, 2026 — classified as 6 injuries, 1,140 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (792 reports).
4 FDA recall records name this device's identifier, 3 still open.
4 other recalls cover devices cleared under the same FDA submission (K250862); 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
- Dec 4, 2023Class IIOpen, Classified
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Z-0687-2024 · 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-2500-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Jul 20, 2022Class IITerminated
The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.
Z-1559-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image792
- Communication or Transmission Problem139
- Erratic or Intermittent Display117
- Poor Quality Image88
- Display or Visual Feedback Problem40
- Image Display Error/Artifact16
- Connection Problem6
- Detachment of Device or Device Component6
Patient problems
- No Clinical Signs, Symptoms or Conditions1,125
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Insufficient Information8
- No Known Impact Or Consequence To Patient2
- Pneumothorax2
- Chest Pain1
- Dyspnea1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 1,146 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026No Display/Image
The customer returned the scope to the service center for a separate issue. During the device analysis, no image was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931521 ↗MalfunctionSep 25, 2026No Display/Image; Poor Quality Image
The customer reported screen turned black during an unspecified diagnostic procedure involving an Olympus Bronchovideoscope. The procedure was completed with an Olympus back-up device and there was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899318 ↗MalfunctionSep 25, 2026Poor Quality Image
The customer reported a bad image when it retroflexes during reprocessing involving an Olympus Bronchovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896755 ↗MalfunctionSep 25, 2026Erratic or Intermittent Display
It was reported the Bronchovideoscope image went black during flexing. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893114 ↗MalfunctionSep 24, 2026Erratic or Intermittent Display
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the Image goes out when flexed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884601 ↗MalfunctionSep 24, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876620 ↗MalfunctionSep 22, 2026Erratic or Intermittent Display; Image Display Error/Artifact
It was reported that the BronchoVideoscope exhibited an image issue (image flickers during angulation). The malfunction was identified during reprocessing. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855910 ↗MalfunctionSep 22, 2026Erratic or Intermittent Display; Image Display Error/Artifact
It was reported that during reprocessing, the bronchovideoscope had an image issue. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855334 ↗MalfunctionSep 22, 2026No Display/Image; Communication or Transmission Problem
The customer reported a no image malfunction involving an Olympus BRONCHOVIDEOSCOPE. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854283 ↗MalfunctionSep 21, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848070 ↗MalfunctionSep 21, 2026Erratic or Intermittent Display; No Display/Image
The customer reported no visual displayed and only showing static during set-up involving an Olympus Bronchovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843932 ↗MalfunctionSep 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842375 ↗MalfunctionSep 21, 2026No Display/Image
It was reported the Bronchovideoscope exhibited black images on the screen. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839785 ↗MalfunctionSep 19, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831781 ↗MalfunctionSep 16, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796951 ↗MalfunctionSep 16, 2026No Display/Image
It was reported that the Broncho Videoscope exhibited the light turns off when moving tip of scope. The malfunction was identified during reprocessing. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791295 ↗MalfunctionSep 15, 2026No Display/Image
The customer returned the BronchoVideoscope for a separate issue. During the device analysis, it was observed that no image was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776369 ↗MalfunctionSep 11, 2026Failure to Disinfect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739964 ↗MalfunctionSep 8, 2026No Display/Image
It was reported that the scope had no image. The issue was found during reprocessing. No harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671487 ↗MalfunctionSep 2, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573288 ↗MalfunctionSep 2, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568647 ↗MalfunctionSep 1, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545699 ↗MalfunctionAug 31, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521296 ↗MalfunctionAug 30, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50512910 ↗MalfunctionAug 28, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507914 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K250862. One submission often covers many models, so check the product and lot details in each record.
- Z-0048-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
- Z-0052-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-H1100
- Z-0057-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
- Z-0066-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
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
- 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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