BRONCHOFIBERSCOPE BF-TE2 (UDI 04953170339998)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus BF-TE2 bronchofiberscope, a flexible scope used to look into the airways, has 105 reports, no deaths and 5 injuries. Some reports describe dents, scratches, breaks, or tears, and a few describe inadequate cleaning. There are 3 recalls, all still open, over instructions for use with laser and other energy devices, a scope that can lodge in an endotracheal tube connector, and possible burning inside the airway during laser procedures.
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
- 113
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 04953170339998), received between Sep 4, 2020 and Sep 29, 2026 — classified as 5 injuries, 108 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (24 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Sep 11, 2025Open, 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-0064-2026 · Root cause: Device Design · FDA record ↗
- Jul 27, 2023Open, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2490-2023 · Root cause: Labeling Change Control · FDA record ↗
- Jun 8, 2023Open, Classified
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Z-2012-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Deformation24
- Failure to Clean Adequately14
- Break13
- Scratched Material13
- Material Split, Cut or Torn11
- Corroded9
- Peeled/Delaminated8
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- No Consequences Or Impact To Patient3
- Pneumothorax3
- Bronchospasm1
- Hemorrhage/Blood Loss/Bleeding1
- Hypoxia1
Recent adverse event reports
The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation; Failure to Clean Adequately
The customer returned the Bronchofiberscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that the Connecting Tube was sticky and the Forceps Channel Port was shaved. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932277 ↗MalfunctionSep 28, 2026Corroded
The customer returned the Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, a corroded forceps channel port was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917550 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903034 ↗MalfunctionSep 22, 2026Corroded
The customer returned the bronchofiberscope to the service center for a separate issue. During the device analysis, it was indicated that corrosion on the light guide cover glass unit was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856744 ↗MalfunctionSep 18, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828727 ↗MalfunctionSep 11, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734740 ↗MalfunctionSep 8, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672702 ↗MalfunctionSep 2, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573100 ↗MalfunctionMay 6, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE FORCEPS CHANNEL PORT HAD A DENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25103871 ↗MalfunctionApr 1, 2026Contamination; Dent in Material; Failure to Clean Adequately
ADDITIONAL FINDINGS FROM THE OLYMPUS SERVICE CENTER: CONNECTING TUBE HAS DIRT DEPOSITION ON IT AND THE INTERNAL FORCEPS CHANNEL PORT HAS A DENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753591 ↗MalfunctionMar 25, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE CHANNEL PORT CORRODED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690567 ↗MalfunctionMar 25, 2026Material Split, Cut or Torn; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THAT THE GRIP, THE UNIVERSAL CORD, THE LIGHT GUIDE ARE ALL STICKY AND THE FORCEPS CHANNEL PORT IS SHAVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688284 ↗MalfunctionMar 25, 2026Dent in Material; Material Deformation
IT WAS OBSERVED THAT DURING THE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THAT THE FORCEPS CHANNEL PORT HAS A DENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688000 ↗MalfunctionMar 17, 2026Device Reprocessing Problem; Corroded; Degraded
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE RETURNED BRONCHOFIBERSCOPE EXHIBITED FORCEPS CHANNEL PORT STICKY AND SHAVED, AND THE CONTROL UNIT DISPLAYED CORROSION DUE TO WATER LEAKAGE. NO PATIENTS WERE INVOLVED IN ASSOCIATION WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616634 ↗MalfunctionMar 12, 2026Corroded; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE FORCEPS CHANNEL PORT WAS SHAVED, LIGHT GUIDE COVER GLASS HAD CORROSION, AND THE ELECTRICAL CONTACT OF THE EYEPIECE HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578813 ↗MalfunctionMar 11, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE HAD A DENT ON THE FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575360 ↗MalfunctionFeb 27, 2026Corroded; Degraded
DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE WAS FOUND TO HAVE CORROSION ON THE SUCTION CYLINDER AND THE BIOPSY PORT WAS SHAVED OFF. NO PATIENTS WERE INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474872 ↗MalfunctionFeb 25, 2026Corroded
DURING THE DEVICE EVALUATION, THE VIDEOSCOPE WAS FOUND TO HAVE CORROSION ON THE CONTROL UNIT DUE TO WATER LEAKAGE. NO PATIENTS WERE INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442480 ↗MalfunctionFeb 17, 2026Detachment of Device or Device Component; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE HAD FORCEPS CHANNEL PORT SHAVED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370054 ↗MalfunctionFeb 13, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE EXHIBITED THE FORCEPS CHANNEL PORT HAD A DENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24338346 ↗MalfunctionJan 30, 2026Degraded
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE FORCEPS CHANNEL PORT ON THE BRONCHOFIBERSCOPE WAS SHAVED. NO PATIENTS WERE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24227188 ↗MalfunctionDec 17, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE EVALUATION THAT BRONCHOFIBERVIDEOSCOPE FORCEPS CHANNEL PORT WAS STICKY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835299 ↗MalfunctionDec 5, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THAT THE FORCEPS CHANNEL PORT IS STICKY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729081 ↗MalfunctionOct 27, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE ADHESIVE ON THE BENDING SECTION COVER IS DETACHED AND THE CONNECTING TUBE HAS PEELING COATING. (1 MM 2 OR MORE) ON THE BRONCHOFIBERSCOPE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23398027 ↗MalfunctionOct 15, 2025Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THE FORCEPS CHANNEL PORT WAS SHAVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285283 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.