OES BRONCHOFIBERSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
9 open recalls name at least one OES BRONCHOFIBERSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 211
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 9
We found 11 models of OES BRONCHOFIBERSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 211 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2020 and Aug 27, 2026 — classified as 22 injuries, 189 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (124 reports).
9 FDA recall records name at least one of these models by its device identifier, 9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
OES BRONCHOFIBERSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-0058-2026 · Root cause: Device Design · Recall details · FDA record ↗
- 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-0047-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Oct 12, 2023Open, 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 · names 2 of these models · Recall details · FDA record ↗
- Sep 25, 2023Open, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0327-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2502-2023 · Root cause: Labeling Change Control · names 3 of these models · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2491-2023 · Root cause: Labeling Change Control · names 2 of these models · Recall details · 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 · names 6 of these models · Recall details · FDA record ↗
- Jun 8, 2023Open, Classified
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Z-2011-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2022Open, Classified
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Z-1046-2022 · Root cause: Other · Recall details · FDA record ↗
Most reported OES BRONCHOFIBERSCOPE problems
Device problems
- Peeled/Delaminated124
- Microbial Contamination of Device14
- Failure to Clean Adequately13
- Contamination /Decontamination Problem10
- Break9
- Adverse Event Without Identified Device or Use Problem8
- Device Reprocessing Problem7
- Thermal Decomposition of Device6
Patient problems
- No Clinical Signs, Symptoms or Conditions186
- Fungal Infection17
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Patient Involvement3
- Drug Resistant Bacterial Infection2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
OES BRONCHOFIBERSCOPE models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls19 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls66 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60BRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls11 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XP60BRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls8 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60BRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls7 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 3C40BRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls1 report
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60BRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls1 report
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60BRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls0 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 3C40BRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall46 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XP60BRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall45 reports
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE N20BRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall7 reports
Recent OES BRONCHOFIBERSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Peeled/Delaminated
No additional information received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465136 ↗MalfunctionJul 30, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086717 ↗MalfunctionApr 21, 2026Corroded; Residue After Decontamination
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF POOR IMAGE QUALITY. 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, EYEPIECE HAD FOREIGN OBJECTS AND FORCEPS CHANNEL PORT HAD CORROSION WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939293 ↗MalfunctionMar 31, 2026Detachment of Device or Device Component
THE BRONCHOFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF WATER LEAKAGE FROM UNIVERSAL CORD, AND SLIGHT INDENTATIONS AND WRINKLES ON THE INSERTION TUBE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CHIPS ON THE DISTAL END COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744665 ↗MalfunctionMar 25, 2026Corroded; Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OES BRONCHOFIBERSCOPE FORCEPS CHANNEL PORT HAS CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689934 ↗MalfunctionAug 29, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920170 ↗MalfunctionJul 29, 2025Corroded; Material Discolored; Corroded; Material Discolored
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED A CORRODED FOREIGN MATERIAL ON THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649031 ↗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 ↗MalfunctionFeb 7, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT DURING REPROCESSING, THE FLEXIBLE SCOPE DID NOT PASS STERILIZATION, TESTED ON 3 DIFFERENT STERILIZERS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21337159 ↗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 14, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE BRONCHOFIBERSCOPE HAD IMAGE PROBLEM. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20683339 ↗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 11, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OES BRONCHOFIBERSCOPE EXHIBITED THE COATING PEELING ON THE CONNECTING TUBE . THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652109 ↗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 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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