EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 (REF N4503920)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
5 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III is a flexible bronchoscope. Of the 595 reports naming it, many describe no image on the display or communication failures. The reports include 32 injuries and 3 deaths, and reports rose from 99 in the previous 12 months to 192 in the latest 12 months. All 5 recalls are open, covering fire risk during cautery, possible infection from wet channels, cleaning instructions and a scope lodging in a breathing tube connector.
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
- 621
- Deaths reported
- 3
- Injuries reported
- 34
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 621 adverse event reports that list this exact device (DI 04953170342110), received between May 31, 2018 and Sep 30, 2026 — classified as 3 deaths, 34 injuries, 584 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (232 reports).
5 FDA recall records name this device's identifier, 5 still open.
3 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
- 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-0057-2026 · Root cause: Device Design · Recall details · FDA record ↗
- 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-0686-2024 · Root cause: Under Investigation by firm · 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-0194-2024 · 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 ↗
Most reported problems
Device problems
- No Display/Image232
- Communication or Transmission Problem115
- Poor Quality Image39
- Erratic or Intermittent Display35
- Detachment of Device or Device Component34
- Peeled/Delaminated24
- Thermal Decomposition of Device23
- Adverse Event Without Identified Device or Use Problem20
Patient problems
- No Clinical Signs, Symptoms or Conditions580
- Pneumothorax13
- Bacterial Infection10
- Hemorrhage/Blood Loss/Bleeding8
- Hypoxia5
- Pneumonia5
- No Known Impact Or Consequence To Patient4
- Air Embolism2
Recent adverse event reports
The 25 most recent of 621 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Break; Detachment of Device or Device Component
It was reported that during a bronchoscopy procedure, a little piece of the bottom by the lens of the bronchovideoscope came off and fell into the patient's lung. The broken piece was retrieved successfully with suction. No additional medical intervention or monitoring was required. There were no further reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948988 ↗InjurySep 30, 2026Break; Detachment of Device or Device Component
It was reported that during a bronchoscopy procedure, a little piece of the bottom by the lens of the bronchovideoscope came off and fell into the patient's lung. The broken piece was retrieved successfully with suction. No additional medical intervention or monitoring was required. There were no further reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948891 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the 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 50946861 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
The customer returned the BRONCHOVIDEOSCOPE to the service center for a separate issue. During the device analysis, the investigator indicated the objective lens is missing glue, and the light guide lens is chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899660 ↗MalfunctionSep 24, 2026Erratic or Intermittent Display; No Display/Image
It was reported that the BronchoVideoscope exhibited they are not getting any picture. The malfunction was identified during set up / inspection for use. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889009 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device it was observed, the distal plastic end was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878047 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876568 ↗MalfunctionSep 23, 2026No Display/Image; Image Display Error/Artifact; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874105 ↗MalfunctionSep 23, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873625 ↗MalfunctionSep 22, 2026No Display/Image
The customer returned the BRONCHOVIDEOSCOPE to the service center for a separate issue. During the device analysis, the investigator indicated there was no image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860052 ↗MalfunctionSep 21, 2026Material Fragmentation; Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847858 ↗MalfunctionSep 21, 2026Erratic or Intermittent Display
The customer reported the bronchovideoscope camera was not working when flexing scope. The issue was found during reprocessing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845371 ↗MalfunctionSep 21, 2026No Display/Image
It was reported the Bronchovideoscope exhibited no picture. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842851 ↗MalfunctionSep 18, 2026Material Split, Cut or Torn
During onsite inspection of the Bronchovideoscope, it was found that the distal end plastic cover lifted. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819461 ↗MalfunctionSep 17, 2026Corroded; Communication or Transmission Problem
During the initial evaluation of the scope it was observed, that there was a B30 error code and corrosion on the distal end cover and light guide lens. No harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803398 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
It was reported that the port of the instrument channel of the scope was pulled off. No harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775286 ↗MalfunctionSep 15, 2026Thermal Decomposition of Device; Electrical /Electronic Property Problem
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device it was observed, the plastic distal end cover at the channel opening was burned. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771789 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, inspection findings from the Repair Center found a chipped distal end plastic cover around the channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755456 ↗MalfunctionSep 14, 2026No Display/Image
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation, it was observed that the device had a black image. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753098 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device it was observed, glue was missing from the objective lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733841 ↗MalfunctionSep 10, 2026Corroded; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716460 ↗MalfunctionSep 9, 2026Communication or Transmission Problem; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680909 ↗MalfunctionSep 2, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576727 ↗MalfunctionSep 1, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543714 ↗MalfunctionAug 31, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50522059 ↗
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-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
- 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-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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