EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190Recalls & 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 bronchoscope has 122 adverse event reports, with 2 deaths and 11 injuries. Many reports describe blank screens, burned or chipped plastic at the tip, and communication failures. Five open recalls name this device, mainly for fire risk during laser or high-frequency therapy, possible infection from wet channels, and the scope getting stuck in a connector. Reports rose from 28 in the previous year to 47 in the latest year.
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
- 127
- Deaths reported
- 2
- Injuries reported
- 11
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 04953170402470), received between Mar 4, 2022 and Sep 25, 2026 — classified as 2 deaths, 11 injuries, 114 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (34 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-0066-2026 · 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-0193-2024 · 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-2498-2023 · 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
- No Display/Image34
- Thermal Decomposition of Device22
- Communication or Transmission Problem14
- Adverse Event Without Identified Device or Use Problem10
- Detachment of Device or Device Component9
- Melted6
- Poor Quality Image6
- Electrical /Electronic Property Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions115
- Unspecified Infection6
- Cardiac Arrest2
- Hemorrhage/Blood Loss/Bleeding2
- Pneumothorax2
- Burn(s)1
- Insufficient Information1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Crack; No Display/Image
The customer reported no image during reprocessing involving an Olympus Bronchovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897217 ↗MalfunctionSep 23, 2026Corroded
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the LG lens is corroded. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870946 ↗MalfunctionSep 8, 2026Communication or Transmission Problem
The customer returned the Bronchovideoscope for a separate issue. During the initial evaluation of the device, it was observed no communication between the plug unit and the processor. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668179 ↗MalfunctionSep 1, 2026Image Display Error/Artifact
The customer reported the Bronchovideoscope when turned on in any direction lines were on the monitor during setup. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535634 ↗MalfunctionAug 28, 2026Break; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503820 ↗MalfunctionAug 27, 2026Thermal Decomposition of Device; Electrical /Electronic Property Problem; Material Fragmentation
The customer returned the BronchoVideoscope for a separate issue. During the device analysis, it was observed that Distal end Plastic Cover burn at channel opening and Distal end Plastic Cover chip was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479960 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458963 ↗MalfunctionAug 24, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418497 ↗MalfunctionAug 13, 2026Material Puncture/Hole
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 found chipped inside channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237854 ↗MalfunctionAug 5, 2026Thermal Decomposition of Device
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician found that the plastic distal end cover was burned. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50141205 ↗MalfunctionAug 4, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134703 ↗MalfunctionJul 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105007 ↗MalfunctionJul 28, 2026Thermal Decomposition of Device
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that a burnt plastic distal end cover was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056597 ↗MalfunctionJun 19, 2026Thermal Decomposition of Device
THE CUSTOMER RETURNED THE BRONCHOVIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING INSPECTION IT WAS FOUND THAT THE DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566336 ↗MalfunctionMay 28, 2026Thermal Decomposition of Device; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE HAD A BURN AND A CHIP ON THE C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323346 ↗MalfunctionMay 28, 2026Thermal Decomposition of Device
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF MINOR LEAK. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, BURNT C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322056 ↗MalfunctionMay 4, 2026Electrical /Electronic Property Problem; Flare or Flash
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF IT JUST COLLAPSED. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, BURNT PLASTIC DISTAL END COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25067965 ↗MalfunctionMay 1, 2026Obstruction of Flow
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF INTERNAL DAMAGE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, SUCTION FLOW WAS LOW DUE TO OBSTRUCTION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056730 ↗MalfunctionMay 1, 2026Material Fragmentation
THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING ONSITE INSPECTION OF BRONCHOVIDEOSCOPE, PLASTIC DISTAL END COVER CHIPPED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056404 ↗MalfunctionApr 29, 2026Degraded; Image Display Error/Artifact
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE OBJECTIVE LENS HAD GLUE MISSING AND THE IMAGE HAD STATIC, WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038411 ↗MalfunctionApr 28, 2026Peeled/Delaminated
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THAT THE TIP OF SCOPE WAS PEELING. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE BENDING RUBBER GLUE WAS MISSING WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024128 ↗MalfunctionApr 23, 2026Detachment of Device or Device Component
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF TIP OF SCOPE BROKEN. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, DISTAL END PLASTIC COVER IS PARTIALLY MISSING WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967416 ↗MalfunctionApr 3, 2026Break
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF LEAK. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, OBJECTIVE LENS HAS CHIPPED GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779458 ↗MalfunctionApr 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD THE CAMERA DETACH FROM THE DISTAL END. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765491 ↗MalfunctionApr 2, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED INTERMITTENT FLICKERING IN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765079 ↗
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-0057-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
- Z-0052-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-H1100
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
- 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
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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