EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 (REF N4503922)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III BRONCHOVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA bronchoscope is a flexible scope for viewing the airways. Reports most often describe no display or image, overheating and communication errors. The database holds 243 reports, including no deaths and 4 injuries, with 239 malfunctions. There is 1 open recall, from July 2023, because the scope can get lodged in an endotracheal tube connector. Reports fell over the last year (3) compared with the year before (74).
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
- 243
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 243 adverse event reports that list this exact device (DI 04953170434983), received between Dec 29, 2022 and Apr 13, 2026 — classified as 4 injuries, 239 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (93 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K250862); they may or may not involve this specific model.
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
- Jul 27, 2023Class IIOpen, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2500-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image93
- Thermal Decomposition of Device66
- Communication or Transmission Problem44
- Peeled/Delaminated13
- Failure to Clean Adequately11
- Microbial Contamination of Device5
- Component Missing3
- Melted3
Patient problems
- No Clinical Signs, Symptoms or Conditions243
Recent adverse event reports
The 25 most recent of 243 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Material Split, Cut or Torn
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THE TERMINAL COVER HAD A CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858932 ↗MalfunctionApr 9, 2026Suction Failure
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF BIOPSY CHANNEL LEAKAGE. 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, NO SUCTION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830823 ↗MalfunctionFeb 11, 2026Mechanical Problem
IT WAS REPORTING DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, THE MOVEMENT LEVER LOCKED ON THE BRONCHOVIDEOSCOPE. THERE WAS NO PATIENT HARM OR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313132 ↗MalfunctionOct 29, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A B30 ERROR DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23418068 ↗MalfunctionSep 16, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23067420 ↗MalfunctionAug 25, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN IMAGE FAILURE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891775 ↗MalfunctionJun 16, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED AN IMAGE TRANSMISSION FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212703 ↗MalfunctionApr 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE BRONCHO VIDEOSCOPE DISPLAYED A B30 ERROR CODE (SCOPE COMMUNICATION ERROR). THE ISSUE OCCURRED DURING INSPECTION BEFORE USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21883345 ↗MalfunctionMar 17, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE DISTAL END BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THE REPORTABLE MALFUNCTION WAS IDENTIFIED BY OLYMPUS DURING DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620287 ↗MalfunctionJan 10, 2025Intermittent Communication Failure; Intermittent Communication Failure
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21125868 ↗MalfunctionDec 10, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE SCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894551 ↗MalfunctionDec 6, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A COMMUNICATION ERROR. THE ISSUE OCCURRED DURING SETUP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20872446 ↗MalfunctionDec 5, 2024Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854258 ↗MalfunctionDec 3, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED 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 20835529 ↗MalfunctionNov 19, 2024Output Problem; Output Problem
IT WAS REPORTED, THE BRONCHOVIDEOSCOPE HAD AN ERROR E238 APPEAR ON SCREEN. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20727772 ↗MalfunctionNov 15, 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 20695144 ↗MalfunctionNov 15, 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 20695100 ↗MalfunctionNov 15, 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 20694888 ↗MalfunctionNov 15, 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 20694778 ↗MalfunctionNov 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, 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 20694742 ↗MalfunctionNov 15, 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 20694495 ↗MalfunctionNov 14, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED 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 20692195 ↗MalfunctionNov 14, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED 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 20690202 ↗MalfunctionNov 14, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED, THAT DURING DEVICE EVALUATION. THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED 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 20690087 ↗MalfunctionNov 13, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED A BURNED OR MELTED PLASTIC DISTAL END COVER 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 20679959 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K250862. One submission often covers many models, so check the product and lot details in each record.
- Z-0057-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
- Z-0066-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
- Z-0048-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
- Z-0052-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-H1100
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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