EVES EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UC190FRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EUS ultrasound bronchoscope is a flexible scope with an ultrasound probe used to view the airways and nearby tissue. The 998 reports often describe the display or image failing, communication faults, and parts detaching or chipping. There are 64 injury reports and no deaths. Reports rose from 227 in the prior 12 months to 340 in the last 12. 2 recalls are open, covering water left in the scope's channel after repair, which could allow contamination, and a scope that can get stuck 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
- 1,082
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,082 adverse event reports that list this exact device (DI 04953170399831), received between Jan 7, 2021 and Sep 30, 2026 — classified as 68 injuries, 1,014 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (271 reports).
2 FDA recall records name this device's identifier, 2 still open.
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 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-0328-2024 · 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-2494-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image271
- Communication or Transmission Problem187
- Detachment of Device or Device Component170
- Failure to Clean Adequately86
- Poor Quality Image74
- Material Fragmentation73
- Break49
- Device Reprocessing Problem41
Patient problems
- No Clinical Signs, Symptoms or Conditions1,053
- Foreign Body In Patient15
- Insufficient Information4
- Subclinical Infection4
- No Consequences Or Impact To Patient2
- Pulmonary Emphysema2
- Upper Respiratory Tract Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 1,082 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952642 ↗MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951814 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was observed that during the device inspection, the Bronchofibervideoscope exhibited the C-BODY ¿ was chipped at probe unit tip. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951296 ↗MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950534 ↗MalfunctionSep 30, 2026Erratic or Intermittent Display
The customer returned the Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, an intermittent/flickering image was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950087 ↗MalfunctionSep 30, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949987 ↗MalfunctionSep 30, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949138 ↗MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem
The customer reported an Error code E226 and when the customer shut it down the scope still did not work. The issue occurred during preparation for use and before the patient was in the procedure room. The issue involved an Olympus Ultrasound Bronchofibervideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946090 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported the Distal End was partially detached during preparation for use and before the patient was in the procedure room. The issue involved an Olympus Ultrasound Bronchofibervideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945564 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported the BRONCHOFIBERVIDEOSCOPE'S sheath came off the distal tip. The issue was found during reprocessing..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941794 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941333 ↗MalfunctionSep 29, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938311 ↗MalfunctionSep 29, 2026Contamination
The customer returned the Bronchofibervideoscope for another issue. The device was returned unrepaired to customer as biohazard. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935953 ↗MalfunctionSep 29, 2026No Display/Image; Communication or Transmission Problem
The customer reported the scope was giving an unspecified communication error message during preparation for use and before the patient was in the procedure room. The issue involved an Olympus Ultrasound Bronchofibervideoscope. Additionally, during the device analysis, the Olympus Service Repair Technician indicated that a B30 scope communication error message and no image was found. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931831 ↗MalfunctionSep 29, 2026No Display/Image
It was reported that the camera image was not showing. Unsure as to when the unspecified procedure occurred involving an Olympus Bronchofibervideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930963 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
The customer reported that device failed in the Medivator, involving an Olympus bronchofibervideoscope. There was no patient injury involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923509 ↗MalfunctionSep 28, 2026Material Fragmentation
The customer returned the Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, a chip on the distal end was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920965 ↗MalfunctionSep 28, 2026Material Fragmentation
The customer returned the Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, a chip on distal end was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919288 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
The customer reported the channel that connects to the handle was coming loose and coming apart. The issue occurred during reprocessing. The issue involved an Olympus Ultrasound Bronchofibervideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913924 ↗MalfunctionSep 25, 2026Material Separation; Unintended Movement
The customer reported that there was a gap and movement on the introduction portion of the scope that occurred during a diagnostic Endobronchial Ultrasound (EBUS) involving an Olympus Broncho fiber videoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899719 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
The customer returned the Ultrasound Bronchofibervideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that there was a cut on the probe unit pink rubber. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897808 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
It was observed that during the device inspection, the Bronchofibervideoscope exhibited C-body was chipped. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896051 ↗MalfunctionSep 24, 2026Material Fragmentation
The customer returned the Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, a chipped probe tip was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886594 ↗MalfunctionSep 24, 2026Material Fragmentation
The customer returned the Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that the distal end was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886051 ↗MalfunctionSep 24, 2026Material Fragmentation
The customer returned the Ultrasound Bronchofibervideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that a chip at the Pink Probe was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882264 ↗
Other Ultrasound bronchoscope devices
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope2 recalls4 deaths1,088 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope35 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope18 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope8 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope4 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.
How reports and recalls are matched · Editorial policy · Report an error on this page