OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 (UDI 04953170339196)Recalls & reported problems
Olympus Medical Systems Corp. · BF-P60 5.0MM DIA 2.2MM CH 60CM LENGTH · Class 2
All models of OES BRONCHOFIBERSCOPE (11)
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 BF-P60 bronchoscope is a thin, flexible scope used to look inside the airways. Its 66 reports mostly describe the outer coating peeling or flaking off, along with contamination, residue or melting at the tip from heat, and cleaning or reprocessing difficulties. No deaths and two injuries were reported. Three recalls name this device, all open, covering instructions for laser and high-frequency use, a fire risk in the airway when oxygen is given during cauterization, and a tip that can get stuck in the 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
- 66
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04953170339196), received between Jan 8, 2021 and Jun 26, 2025 — classified as 2 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (39 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-0058-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Oct 12, 2023Class IOpen, Classified
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
Z-0189-2024 · 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-2490-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Peeled/Delaminated39
- Microbial Contamination of Device10
- Device Reprocessing Problem4
- Failure to Clean Adequately4
- Thermal Decomposition of Device4
- Break2
- Melted2
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Drug Resistant Bacterial Infection2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025No Display/Image; Failure to Clean Adequately; No Display/Image; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED NO IMAGE AS WELL AS CRYSTALLIZATION IN THE CONTROL BODY AND THE EYEPIECE SECTIONS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336515 ↗MalfunctionNov 14, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE EXHIBITED DETERIORATION OF THE COATING OF THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20683657 ↗MalfunctionNov 11, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED/MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20653826 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHO VIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644652 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHO VIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644432 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20642757 ↗MalfunctionOct 14, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE WAS REPROCESSED IN AN ENDOSCOPE REPROCESSOR (OER-4) THAT HAD A STICKY WHITE SUBSTANCE IN IT¿S TOP COVER. IT WAS ALSO NOTED THAT THE USER FACILITY STAFFED UTILIZED THE DEVICE IN A PROCEDURE. THE ISSUE WAS FOUND DURING REPROCESSING AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20441069 ↗MalfunctionOct 8, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE¿S IMAGE GUIDE HOSE COATING WAS PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20403294 ↗MalfunctionSep 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOFIBERSCOPE¿S CONNECTING TUBE COATING WAS PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20274861 ↗MalfunctionSep 5, 2024Peeled/Delaminated; Device Markings/Labelling Problem; Peeled/Delaminated; Device Markings/Labelling Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE HAD TUBE COATING PEELED, AND INSERTION SECTION FLEXIBLE TUBE DISPLAY DISAPPEARED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146715 ↗MalfunctionSep 3, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE EXHIBITED THE COATING OF THE IMAGE GUIDE HOSE PEELED OFF (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20130496 ↗MalfunctionJun 24, 2024Melted; Melted
IT WAS REPORTED THAT THE PLASTIC DISTAL END COVER AND TIP OF THE BRONCHOFIBERSCOPE WERE BURNT/MELTED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19594447 ↗MalfunctionJun 12, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED CONNECTING TUBE HAD COATING PEELED AND SOFT TUBE MARKING DISAPPEARED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525466 ↗MalfunctionMay 20, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE BRONCHOFIBERSCOPE WAS PROCESSED WITHOUT THE ETO CAP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19350987 ↗MalfunctionMay 8, 2024Device Reprocessing Problem; Device Reprocessing Problem
OLYMPUS WAS INFORMED THAT DURING REPROCESSING BY STAFF OF A BRONCHOFIBERSCOPE, IT WAS REPORTED THAT INSUFFICIENT REPROCESSING OCCURRED, AS THE SCOPE WAS PROCESSED WITHOUT THE ETHYLENE OXIDE GAS VALVE CAP IN PLACE. NO PATIENT INFECTIONS OR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266852 ↗MalfunctionApr 26, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED PEELING OF COATING ON THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19190966 ↗MalfunctionApr 9, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE TUBE COATING OF THE BRONCHOFIBERSCOPE INSERTION PART HAD PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19069950 ↗MalfunctionApr 7, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSOCPE EXHIBITED THAT THE INSERTION SECTION FLEXIBLE TUBE COATING HAD PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19057013 ↗MalfunctionMar 17, 2024Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OES BRONCHOFIBERSCOPE EXHIBITED THE COATING OF THE IMAGE GUIDE PIPE WAS PEELING OFF AND THE PLASTIC DISTAL END COVER WAS MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18919113 ↗MalfunctionMar 14, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED COATING PEELING ON THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18905854 ↗MalfunctionMar 14, 2024Melted; Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED A BURNED PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18904104 ↗MalfunctionFeb 26, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE COAT OF THE IMAGE GUIDE PIPE IS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18784037 ↗MalfunctionJan 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THE BRUSH TIP, THE OBJECTIVE LENS AND THE LIGHTING LENS TIP HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18573724 ↗MalfunctionJan 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES BRONCHOFIBERSCOPE HAD AIR/WATER LEAKAGES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT THE CHANNEL TUBE HAD FOREIGN MATERIAL. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18474937 ↗MalfunctionDec 22, 2023Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOFIBERSCOPE HAD A RUBBER PINHOLE. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE COAT OF THE IMAGE GUIDE PIPE WAS PEELING OFF. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18387541 ↗
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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