EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 (UDI 04953170335198)Recalls & reported problems
Olympus Medical Systems Corp. · BF-Q190 EEIII Q-IMAGE DIAGNOST IC BRONCH · 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 is a camera scope used in the airways. Of its 274 reports, 20 are injury reports and 254 are malfunction reports, with no deaths. Many describe a blank screen or poor transmission, and some mention infections. There are 5 open recalls, covering fire risk during laser use, wet scope channels and lodging in a 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
- 280
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 04953170335198), received between Jul 3, 2018 and Sep 25, 2026 — classified as 20 injuries, 260 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (102 reports).
5 FDA recall records name this device's identifier, 5 still open.
5 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-0063-2026 · 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 ↗
- 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/Image102
- Communication or Transmission Problem74
- Microbial Contamination of Device28
- Device Reprocessing Problem18
- Detachment of Device or Device Component14
- Peeled/Delaminated13
- Poor Quality Image13
- Erratic or Intermittent Display12
Patient problems
- No Clinical Signs, Symptoms or Conditions259
- Fungal Infection14
- Bacterial Infection8
- Pneumonia4
- Aspiration/Inhalation2
- Dyspnea2
- High White Blood Cell Count2
- Pain2
Recent adverse event reports
The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Erratic or Intermittent Display; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902702 ↗MalfunctionSep 25, 2026Corroded; No Display/Image
It was reported the Bronchovideoscope exhibited no picture on the screen. The issue occurred druing reprocessing. There was no patient invovlement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899686 ↗MalfunctionSep 24, 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 detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884240 ↗MalfunctionSep 23, 2026No Display/Image
The customer reported no image on the monitor during inspection for use involving an Olympus Bronchovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867071 ↗MalfunctionSep 21, 2026No Display/Image; Communication or Transmission Problem
The customer reported the Bronchovideoscope generated an Error code B30 during setup/inspection for use. During the initial evaluation of the device, no image was observed after aeration. No patient harm was observed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846659 ↗MalfunctionSep 16, 2026No Display/Image; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794923 ↗MalfunctionAug 26, 2026Scratched Material
The customer reported that the bronchovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the distal end plastic cover exhibited chips. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50451583 ↗MalfunctionAug 17, 2026Failure to Cycle
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50282069 ↗MalfunctionAug 11, 2026No Display/Image; Communication or Transmission Problem
The bronchovideoscope was returned to the service center. During inspection of the device, a B30 error and no image was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204466 ↗MalfunctionAug 11, 2026Dent in Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201355 ↗MalfunctionAug 6, 2026No Visual Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161398 ↗MalfunctionAug 4, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129433 ↗MalfunctionJul 29, 2026Material Separation; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50073412 ↗MalfunctionJul 29, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071141 ↗MalfunctionMay 29, 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 LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340249 ↗MalfunctionMay 1, 2026Degraded
THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING INSPECTION OF THE BRONCHOVIDEOSCOPE THE OBJECTIVE LENS MISSING GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056445 ↗MalfunctionApr 29, 2026Material Fragmentation
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF DENT ON THE INSIDE OF CHANNEL AND HAS SCRATCHES. 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 GLUE IS CHIPPED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031825 ↗MalfunctionApr 23, 2026Degraded
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF PHYSICAL DAMAGE AND CHIPPED. 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, CHIPPED GLUE ON THE OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972232 ↗MalfunctionApr 20, 2026Detachment of Device or Device Component
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF MINOR 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, CHIPPED DISTAL END PLASTIC COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24930959 ↗MalfunctionApr 17, 2026Degraded
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF NOT PROPERLY SEALED NEAR PLUG END OF THE SCOPE. 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, A CHIPPED PLASTIC DISTAL END COVER AT THE CHANNEL OPENING WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24918876 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE INSERTION TUBE WAS DAMAGED. 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, CCD LENS WAS MISSING GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24878374 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF SCOPE IS FLATTENED IN MULTIPLE AREAS. 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, CHIP ON DISTAL END PLASTIC COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874498 ↗MalfunctionApr 13, 2026Melted
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF HAS A LEAK IN THE HANDLE. 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, MELTED PLASTIC DISTAL END COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859289 ↗MalfunctionApr 10, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE HAD COMMUNICATION ERROR IN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838304 ↗MalfunctionApr 9, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE ADHESIVE HAD CHIPPED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834729 ↗
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-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-0053-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
- Z-0060-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- Z-2015-2023 · Jun 8, 2023 · Open, ClassifiedOlympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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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