EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 (REF N4504022)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 III bronchoscope has 228 adverse event reports, including 227 malfunctions, 1 injury and no deaths. The reports mostly describe no image or a poor image on the screen, communication problems and damaged parts. 1 recall, open since July 2023, concerns the scope being too wide for a breathing tube connector. Reports fell from 33 in the previous 12 months to 8 in the most recent 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
- 230
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 04953170434990), received between Mar 14, 2023 and Sep 21, 2026 — classified as 1 injury, 229 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (163 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/Image163
- Communication or Transmission Problem35
- Erratic or Intermittent Display14
- Poor Quality Image12
- Display or Visual Feedback Problem4
- Break3
- Failure to Clean Adequately3
- Electrical /Electronic Property Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions229
- Abdominal Pain1
- Cholangitis1
- Hemorrhage/Blood Loss/Bleeding1
- Pancreatitis1
- Peritonitis1
- Sepsis1
Recent adverse event reports
The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Erratic or Intermittent Display
It was reported the Bronchovideoscope exhibited image interference. The issue occurred during inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838682 ↗MalfunctionSep 14, 2026Erratic or Intermittent Display; No Display/Image
The customer returned the bronchovideoscope for a separate issue. During the initial evaluation of the returned device, no image and the image is noisy were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748113 ↗MalfunctionAug 14, 2026Erratic or Intermittent Display; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260193 ↗MalfunctionJul 29, 2026Suction Failure
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicated that aspiration was not possible due to a dent in the biopsy channel was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50073903 ↗MalfunctionApr 23, 2026No Display/Image
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF LEAK. 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 IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966196 ↗MalfunctionApr 8, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816291 ↗MalfunctionApr 6, 2026No Display/Image
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF CRUSHED INSERTION TUBE, O - CONNECTOR BLOCK, PERFORATED DISTAL TIP RUBBER, IMAGE WITH INTERFERENCE, AND MISALIGNED ANGULATION. 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, THE IMAGE DISAPPEARS DURING ANGULATION IN THE UD DIRECTION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792455 ↗MalfunctionFeb 4, 2026No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXPERIENCED IMAGE LOSS. 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 24261587 ↗MalfunctionNov 26, 2025Poor Quality Image; Poor Quality Image
THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656179 ↗MalfunctionNov 3, 2025No Display/Image; Material Puncture/Hole; No Display/Image; Material Puncture/Hole
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460085 ↗MalfunctionOct 27, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392408 ↗MalfunctionSep 5, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXHIBITED IMAGE INTERFERENCE. THE ISSUE OCCURRED SUIRNG MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976593 ↗MalfunctionAug 26, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE AND INTERMITTENT LIGHT FLASHES ON MONITOR. THE EVENT OCCURRED DURING SET-UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893961 ↗MalfunctionJul 25, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE AND AN E216 SCOPE COMMUNICATION ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608299 ↗MalfunctionJul 22, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE WAS DISPLAYING A POOR-QUALITY IMAGE THAT WOULD BE LOST WITH ANY FLEX OF DISTAL TIP DURING A RIGHT THORACOSCOPY DIAGNOSTIC PROCEDURE. THE EVENT OCCURRED BEFORE THE PATIENT WAS SEDATED AND THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22567302 ↗MalfunctionJul 22, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD "IMAGE BREAKDOWN AT DOWNSIDE ANGLE" IN THE SERVICE LOG. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565373 ↗MalfunctionJul 7, 2025Erratic or Intermittent Display; Power Problem; Erratic or Intermittent Display; Power Problem
IT WAS REPORTED THE BRONCHO VIDEO SCOPE WAS TURNING ON AND OFF RAPIDLY DURING USE. THE ISSUE OCCURRED PRIOR TO USE DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22421751 ↗MalfunctionJun 30, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22365939 ↗MalfunctionJun 10, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22174998 ↗MalfunctionMay 29, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE DEVICE IMAGE DISAPPEARED DURING ANGULATION IN UP/DOWN DIRECTIONS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22108391 ↗MalfunctionMay 23, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079912 ↗MalfunctionApr 21, 2025Poor Quality Image; Poor Quality Image
THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878804 ↗MalfunctionApr 17, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING SET UP/PRIOR TO PATIENT USE, THE SUBJECT FLEX VIDEO SCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21853695 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD TIP RIPPED OFF. THE ISSUE OCCURRED DURING INSPECTION OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631695 ↗MalfunctionMar 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED AN INTERMITTENT/FLICKERING IMAGE WHEN ANGULATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602165 ↗
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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