EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190FRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III bronchoscope is a flexible scope used to look inside the airways. Many of the 82 reports describe no image on the display, communication problems, or contamination. The reports include 13 injuries and no deaths. There are 2 open recalls: one over channels that may stay wet after repair, and one over a scope that can get stuck in an endotracheal tube connector because it is too wide.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04953170395581), received between Oct 24, 2022 and Aug 26, 2026 — classified as 13 injuries, 69 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (25 reports).
2 FDA recall records name this device's identifier, 2 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 25, 2023Class IIOpen, 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 · 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-2497-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image25
- Communication or Transmission Problem20
- Microbial Contamination of Device10
- Adverse Event Without Identified Device or Use Problem8
- Display or Visual Feedback Problem3
- Erratic or Intermittent Display3
- Failure to Clean Adequately3
- Poor Quality Image3
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- Pneumothorax8
- Hemorrhage/Blood Loss/Bleeding6
- Fungal Infection4
- Insufficient Information1
- Low Oxygen Saturation1
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453544 ↗MalfunctionAug 10, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189531 ↗MalfunctionJul 30, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090006 ↗MalfunctionJul 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50064567 ↗MalfunctionJul 27, 2026Erratic or Intermittent Display
The customer returned the BRONCHOFIBERVIDEOSCOPE to the service center for a separate issue. During the device analysis, the investigator indicates a flashing light on image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000246 ↗MalfunctionApr 1, 2026Contamination /Decontamination Problem
THE BRONCHOFIBERVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE RESI TEST END BROKE OFF IN SCOPE; IT WAS STUCK INSIDE SCOPE LUMEN CHANNEL. UNABLE TO DISLODGE. 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, FOUND FOREIGN MATERIAL WAS FOUND INSIDE THE FORCEPS PASSAGE AND THE BRUSH PASSAGE OF THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761170 ↗MalfunctionFeb 19, 2026Contamination /Decontamination Problem
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED STUCK FOREIGN MATERIAL INSIDE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24394195 ↗MalfunctionJan 8, 2026Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOFIBERVIDEOSCOPE EXPERIENCED A COMMUNICATION ERROR CODE B30. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016283 ↗MalfunctionJan 7, 2026Image Display Error/Artifact
CUSTOMER REPORTED " DAMAGED" . THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT. DEVICE INSPECTION FOUND IMAGE NOISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23993386 ↗MalfunctionJan 7, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED IMAGE INTERMITTENTLY FLICKERS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23992936 ↗MalfunctionJan 6, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974754 ↗MalfunctionJan 5, 2026Environmental Particulates
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SCOPE HAD DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959041 ↗MalfunctionDec 23, 2025No Display/Image; Optical Problem; No Display/Image; Optical Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23885112 ↗MalfunctionDec 3, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE IMAGE DISPLAYED INTERMITTENTLY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 23705520 ↗MalfunctionNov 5, 2025No Display/Image; No Display/Image
THE MALFUNCTION OCCURRED WITH A BRONCHOFIBERVIDEOSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479557 ↗MalfunctionOct 23, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOFIBERVIDEOSCOPE ENCOUNTERED A BLACK IMAGE WITH NOISE DUE TO SCOPE CONNECTOR FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373341 ↗MalfunctionSep 2, 2025No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED INTERMITTENT FLICKERING IMAGE WHEN ANGULATING THE ANGULATION LEVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22948744 ↗MalfunctionMar 28, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT US-SCOPE / US-PROBE IMAGE DID NOT APPEAR, JUST BLACK SCREEN WITH SMALL FLECKS OF LIGHT. THERE WAS NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21722069 ↗MalfunctionMar 14, 2025No Display/Image; No Display/Image
THIS ISSUE HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY WERE IT TO RECUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604793 ↗MalfunctionMar 6, 2025Break; Break
IT WAS REPORTED THAT THE BIOPSY PORT WAS BROKEN ON SUBJECT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540926 ↗MalfunctionFeb 19, 2025Flaked; Flaked
IT WAS REPORTED THAT THE BRONCHOFIBERVIDEOSCOPE'S GLUE RING AND SHEATH INSIDE AT THE DISTAL END WERE CHIPPING AWAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21410450 ↗MalfunctionDec 13, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE EVIS EXERA III BRONCHOFIBERVIDEOSCOPE DISPLAYED A B30 ERROR (SCOPE COMMUNICATION ERROR CODE). THE REPORTED MALFUNCTION OCCURRED DURING INSPECTION FOR USE PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20931461 ↗InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ULTRATHIN BRONCHOSCOPY WITHOUT VIRTUAL NAVIGATION FOR DIAGNOSIS OF PERIPHERAL LUNG LESIONS" LITERATURE SUMMARY BACKGROUND: THE INCREASING INCIDENCE OF ENCOUNTERING LUNG NODULES NECESSITATES AN ONGOING SEARCH FOR IMPROVED DIAGNOSTIC PROCEDURES. VARIOUS BRONCHOSCOPIC TECHNOLOGIES HAVE BEEN INTRODUCED OR ARE IN DEVELOPMENT, BUT FURTHER STUDIES ARE NEEDED TO DEFINE A METHOD THAT FITS BEST IN CLINICAL PRACTICE AND HEALTH CARE SYSTEMS. RESEARCH QUESTION HOW DO BASIC BRONCHOSCOPIC TOOLS INCLUDING A COMBINATION OF THIN (OUTER DIAMETER 4.2 MM) AND ULTRATHIN BRONCHOSCOPES (OUTER DIAMETER 3.0 MM), RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) AND FLUOROSCOPY PERFORM IN PERIPHERAL PULMONARY LESION DIAGNOSIS? STUDY DESIGN AND METHODS: THIS IS A RETROSPECTIVE REVIEW OF THE PERFORMANCE OF PERIPHERAL BRONCHOSCOPY USING THIN AND ULTRATHIN BRONCHOSCOPY WITH REBUS AND 2D FLUOROSCOPY WITHOUT A NAVIGATIONAL SYSTEM FOR EVALUATING PERIPHERAL LUNG LESIONS IN A SINGLE ACADEMIC MEDICAL CENTER FROM 11/2015 TO 1/2021. WE USED A STRICT DEFINITION FOR DIAGNOSTIC YIELD AND ASSESSED THE IMPACT OF DIFFERENT VARIABLES ON DIAGNOSTIC YIELD, SPECIFICALLY AFT
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax
MAUDE report 20705626 ↗InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ULTRATHIN BRONCHOSCOPY WITHOUT VIRTUAL NAVIGATION FOR DIAGNOSIS OF PERIPHERAL LUNG LESIONS". LITERATURE SUMMARY: BACKGROUND: THE INCREASING INCIDENCE OF ENCOUNTERING LUNG NODULES NECESSITATES AN ONGOING SEARCH FOR IMPROVED DIAGNOSTIC PROCEDURES. VARIOUS BRONCHOSCOPIC TECHNOLOGIES HAVE BEEN INTRODUCED OR ARE IN DEVELOPMENT, BUT FURTHER STUDIES ARE NEEDED TO DEFINE A METHOD THAT FITS BEST IN CLINICAL PRACTICE AND HEALTH CARE SYSTEMS. RESEARCH QUESTION HOW DO BASIC BRONCHOSCOPIC TOOLS INCLUDING A COMBINATION OF THIN (OUTER DIAMETER 4.2 MM) AND ULTRATHIN BRONCHOSCOPES (OUTER DIAMETER 3.0 MM), RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) AND FLUOROSCOPY PERFORM IN PERIPHERAL PULMONARY LESION DIAGNOSIS? STUDY DESIGN AND METHODS: THIS IS A RETROSPECTIVE REVIEW OF THE PERFORMANCE OF PERIPHERAL BRONCHOSCOPY USING THIN AND ULTRATHIN BRONCHOSCOPY WITH REBUS AND 2D FLUOROSCOPY WITHOUT A NAVIGATIONAL SYSTEM FOR EVALUATING PERIPHERAL LUNG LESIONS IN A SINGLE ACADEMIC MEDICAL CENTER FROM 11/2015 TO 1/2021. WE USED A STRICT DEFINITION FOR DIAGNOSTIC YIELD AND ASSESSED THE IMPACT OF DIFFERENT VARIABLES ON DIAGNOSTIC YIELD, SPECIFICALLY A
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax
MAUDE report 20705596 ↗MalfunctionNov 5, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, A PART OF A NON-OLYMPUS CLEANING BRUSH THAT COULD NOT BE REMOVED, WAS CLOGGED IN THE BIOPSY CHANNEL OF THE BRONCHOFIBERVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609067 ↗
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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