EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 3C160 (UDI 04953170063039)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA BRONCHOVIDEOSCOPE (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170063039), received between Jul 24, 2019 and Aug 7, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier, 1 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
- Jul 27, 2023Class IIOpen, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2503-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
- Display or Visual Feedback Problem1
- No Display/Image1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Poor Quality Image; Poor Quality Image
NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22745932 ↗MalfunctionJul 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
DURING THE PREVENTIVE INSPECTION, IT WAS FOUND THAT THE SCOPE INTERMITTENTLY DISPLAYS IMAGES. NO HARM REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22585351 ↗MalfunctionApr 26, 2023No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE CANNOT ANGULATE SUFFICIENTLY. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING THE FOLLOWING WAS FOUND: NO IMAGE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (NO IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16816874 ↗MalfunctionJul 24, 2019Break; Break
THE MANUFACTURER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE SEAL FROM AROUND THE LENS OF THE SCOPE WAS FOUND INSIDE THE PATIENT'S AIRWAY AFTER INTUBATION. THE PIECE WAS SUCTIONED OUT OF THE ENDOTRACHEAL TUBE (ET) WITHOUT HARM TO THE PATIENT. THE SCOPE WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED USING A NEW SCOPE. IN ADDITION, THE SCOPE WAS INSPECTED PRIOR TO USE AND SHOWED NO VISUAL SIGNS OF DAMAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8822086 ↗MalfunctionJul 24, 2019Break; Break
THE MANUFACTURER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE SEAL FROM AROUND THE LENS OF THE SCOPE WAS FOUND INSIDE THE PATIENT'S AIRWAY AFTER INTUBATION. THE PIECE WAS SUCTIONED OUT OF THE ENDOTRACHEAL TUBE (ET) WITHOUT HARM TO THE PATIENT. THE SCOPE WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED USING A NEW SCOPE. IN ADDITION, THE SCOPE WAS INSPECTED PRIOR TO USE AND SHOWED NO VISUAL SIGNS OF DAMAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8822000 ↗
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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