BRONCHOFIBERSCOPE BF-PE2 (UDI 04953170339974)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 13, 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 bronchofiberscope is a flexible airway scope. Of its 83 reports, 82 are malfunctions and 1 is an injury, with no deaths. Many describe deformed or peeling parts, breaks and cleaning problems. There are 3 open recalls about instructions for use alongside laser equipment, a scope that can lodge in an endotracheal tube connector, and burning during laser procedures. Reports rose to 24 in the last 12 months from 13 in the prior 12 months.
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
- 85
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 04953170339974), received between Mar 25, 2021 and Sep 22, 2026 — classified as 1 injury, 84 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (16 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-0059-2026 · 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 Deformation16
- Failure to Clean Adequately15
- Peeled/Delaminated11
- Break8
- Material Split, Cut or Torn8
- Corroded6
- Scratched Material5
- Degraded3
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- Hemorrhage/Blood Loss/Bleeding1
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Decrease in Suction; Dent in Material
The customer returned the Bronchofiberscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that a reportable malfunction was found. It was determined that the Suction volume does not meet the standard value and the forceps channel port has a dent. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849566 ↗MalfunctionSep 1, 2026Dent in Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543923 ↗MalfunctionSep 1, 2026Dent in Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50540027 ↗MalfunctionAug 31, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521681 ↗MalfunctionAug 20, 2026Corroded; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356657 ↗MalfunctionAug 18, 2026Material Deformation
The customer returned the Bronchofiberscope for a separate issue. During the device evaluation it was noted that the insertion tube port was dented. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301406 ↗MalfunctionAug 17, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286852 ↗MalfunctionAug 13, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243157 ↗MalfunctionAug 12, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50224829 ↗MalfunctionAug 6, 2026Detachment of Device or Device Component; Scratched Material
The customer returned the Bronchofiberscope to the service center for a separate issue. During the device analysis, the service repair technician indicated the adhesive on the bending section cover was detached and the forceps channel port was shaved. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50155740 ↗MalfunctionAug 5, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142065 ↗MalfunctionMay 11, 2026Material Split, Cut or Torn
IT WAS OBSERVED 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 25137671 ↗MalfunctionApr 8, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE FORCEPS CHANNEL PORT WAS SHAVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816405 ↗MalfunctionApr 3, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE BRONCHOFIBERSCOPE'S FORCEPS CHANNEL PORT HAS CORROSION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781948 ↗MalfunctionMar 31, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THE FORCEPS CHANNEL PORT HAS CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744331 ↗MalfunctionMar 30, 2026Device Reprocessing Problem
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE FORCEPS CHANNEL PORT AND THE UNIVERSAL CORD OF THE BRONCHOFIBERSCOPE WERE STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736471 ↗MalfunctionMar 30, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE FORCEPS CHANNEL PORT WAS SHAVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717801 ↗MalfunctionMar 30, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THE FORCEPS CHANNEL PORT WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712454 ↗MalfunctionMar 30, 2026Material Discolored; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THAT THE SUCTION CYLINDER IS FOUND DISCOLORED AND THE FORCEPS CHANNEL PORT IS STICKY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24709320 ↗MalfunctionMar 16, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED A SHAVED OFF FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603419 ↗MalfunctionMar 4, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE EXHIBITED FORCEPS CHANNEL PORT HAD A DENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513151 ↗MalfunctionMar 2, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE FORCEPS CHANNEL PORT WAS SHAVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24488361 ↗MalfunctionFeb 17, 2026Failure to Clean Adequately
CORRECTION: IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED CORROSION ON THE INSERTION TUBE AND BIOPSY FORCEPS PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367254 ↗MalfunctionFeb 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED A STICKY UNIVERSAL CORD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334868 ↗MalfunctionJan 20, 2026Material Deformation
IT WAS FOUND DURING THE EVALUATION THAT THE BRONCHOFIBERSCOPE EXHIBITED THAT THE FORCEPS CHANNEL PORT IS SHAVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24125866 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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