EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 (UDI 04953170339325)Recalls & reported problems
Olympus Medical Systems Corp. · BF-1T180 VIDEOSCOPE 6.0MM DIA 3.0MM CH · Class 2
All models of EVIS EXERA II BRONCHOVIDEOSCOPE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA II bronchoscope is a camera scope for the airways. Its 405 adverse event reports often describe the image going blank, burnt tip covers, and microbial contamination, and some describe bacterial infections. The reports include 1 death and 49 injuries. All 3 recalls are open, over laser burning, instruction updates and a scope size that can jam in a connector. Reports fell from 98 in the earlier year to 27 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
- 408
- Deaths reported
- 1
- Injuries reported
- 49
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 408 adverse event reports that list this exact device (DI 04953170339325), received between Aug 8, 2018 and Sep 2, 2026 — classified as 1 death, 49 injuries, 358 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (162 reports).
3 FDA recall records name this device's identifier, 3 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 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-0046-2026 · Root cause: Device Design · 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-2493-2023 · 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-2016-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image162
- Thermal Decomposition of Device80
- Microbial Contamination of Device45
- Peeled/Delaminated32
- Failure to Clean Adequately22
- Device Reprocessing Problem17
- Melted14
- Break13
Patient problems
- No Clinical Signs, Symptoms or Conditions354
- Bacterial Infection25
- Unspecified Infection14
- Fungal Infection5
- Pneumothorax3
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 408 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026No Display/Image; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563525 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542661 ↗MalfunctionAug 13, 2026No Display/Image
Patient problems: Insufficient Information
MAUDE report 50230619 ↗MalfunctionJul 30, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085265 ↗MalfunctionJul 27, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50042395 ↗MalfunctionApr 30, 2026Break; Crack
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A CLOG IN THE CHANNEL. 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 DISTAL END PLASTIC COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050492 ↗MalfunctionApr 9, 2026Crack
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A 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, CRACKED/CHIPPED PLASTIC DISTAL END COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831583 ↗MalfunctionApr 8, 2026Thermal Decomposition of Device
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, COVER BURNED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816581 ↗MalfunctionFeb 18, 2026Melted
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOVIDEOSCOPE DISTAL END C-COVER HAD A BURNT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378975 ↗MalfunctionFeb 18, 2026Melted
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE PLASTIC DISTAL END COVER WAS BURNED ON THE BRONCHOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377401 ↗MalfunctionFeb 18, 2026Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE WAS BURNT ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24376593 ↗MalfunctionFeb 14, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE DISTAL SHEATH WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341240 ↗MalfunctionFeb 11, 2026No Display/Image; Key or Button Unresponsive/not Working
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312314 ↗MalfunctionFeb 11, 2026Melted
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THE PLASTIC DISTAL END COVER HAD A BURN MARK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311070 ↗MalfunctionFeb 9, 2026Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A BURNT DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298832 ↗MalfunctionFeb 6, 2026Melted
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THE PLASTIC DISTAL END COVER WAS BURNED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24277793 ↗MalfunctionJan 27, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED MISSING SEALING GLUE ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192839 ↗InjuryJan 20, 2026Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Foreign Body In Patient
MAUDE report 24123454 ↗MalfunctionJan 5, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE IMAGE WAS DISTORTED ON THE BRONCHOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957935 ↗MalfunctionJan 2, 2026Component Missing; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE HAD THE OBJECTIVE LENS (IMAGE LENS) MISSING GLUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945114 ↗MalfunctionJan 2, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE HAD INTERMITTENT FLICKER OF IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944889 ↗MalfunctionDec 29, 2025No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT FLEX VIDEO SCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23915417 ↗MalfunctionDec 29, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT FLEX VIDEO SCOPE EXHIBITED A FAILED FLICKER CHECK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23913385 ↗MalfunctionDec 26, 2025Detachment of Device or Device Component; Scratched Material; Detachment of Device or Device Component; Scratched Material
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE HAD THE DISTAL END, C COVER HAVE DENTS, SCRATCHES AND DETACHED FROM BENDING SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895651 ↗MalfunctionDec 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S DISTAL TIP WAS BLOWN DUE TO A MISSING A-RUBBER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23885047 ↗
Other NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)785 reports
- NA 242268Medos International Sàrl · Nasopharyngoscope (flexible or rigid)573 reports
- VIVIDEO VNL9-CPHoya Corporation · Nasopharyngoscope (Flexible Or Rigid)389 reports
- PENTAX FNL-10RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
- SINGLE USE SUCTION VALVE MAJ-209Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)228 reports
- PENTAX FNL-7RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 reports
- PENTAX FNL-10RBSHoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)171 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