EVIS EXERA II BRONCHOVIDEOSCOPE OLYPUS BF TYPE P180 (UDI 04953170339288)Recalls & reported problems
Olympus Medical Systems Corp. · BF-P180 VIDEOSCOPE 4.9MM DIA 2.0MM CH · Class 2
All models of EVIS EXERA II BRONCHOVIDEOSCOPE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus bronchoscope is a narrow-band spectrum endoscope accessory. Most of the 81 reports describe display or image problems, plus cleaning and reprocessing issues. There are 81 reports, no deaths, 1 injury and 80 malfunctions. Four open recalls started in June 2023, July 2023 and September 2025 concern IFU updates for laser or argon plasma coagulation use, the scope lodging in an endotracheal tube connector, and endobronchial combustion during therapeutic laser procedures.
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
- 85
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 04953170339288), received between Oct 7, 2020 and Sep 25, 2026 — classified as 1 injury, 84 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (43 reports).
4 FDA recall records name this device's identifier, 4 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-0056-2026 · Root cause: Device Design · 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-2493-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Jun 8, 2023Class IOpen, Classified
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Z-2016-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 8, 2023Class IOpen, 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 ↗
Most reported problems
Device problems
- No Display/Image43
- Peeled/Delaminated6
- Poor Quality Image6
- Device Reprocessing Problem5
- Erratic or Intermittent Display5
- Failure to Clean Adequately5
- Communication or Transmission Problem3
- Microbial Contamination of Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- No Patient Involvement2
- Fever1
- Shaking/Tremors1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Deformation
The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device it was observed, distal end plastic cover was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897877 ↗MalfunctionSep 24, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889001 ↗MalfunctionSep 22, 2026Device Reprocessing Problem
It was reported that the Bronchovideoscope was sterilized by SPD and the cap was not removed, resulting in a damaged Scope. There was no report of patient harm or involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849930 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576360 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521299 ↗MalfunctionAug 10, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189504 ↗MalfunctionJul 30, 2026Erratic or Intermittent Display
It was observed that during the device evaluation, the Bronchovideoscope's, image flickered then disappeared, when the light guide tube was manipulated. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090529 ↗MalfunctionJul 30, 2026Erratic or Intermittent Display; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078549 ↗MalfunctionApr 16, 2026Material Fragmentation
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A SUSPICION OF A 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, A CHIPPED DISTAL END COVER AT THE INNER AND OUTER CHANNEL OPENING WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895785 ↗MalfunctionApr 11, 2026No Display/Image
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF DULL IMAGE QUIALITY AND AUTO BRIGHTNESS WAS NOT ADJUSTING PROPERLY. 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 24849225 ↗MalfunctionMar 21, 2026No Display/Image
NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24656935 ↗MalfunctionFeb 27, 2026Poor Quality Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXPERIENCED WHITE SPARKLES ON IMAGING. THE IMAGE WENT BLACK WHILE FLEXING THE SCOPE. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, DURING SEDATION (WHILE THE DEVICE WAS INSIDE THE PATIENT). THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469428 ↗MalfunctionFeb 9, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FORM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293804 ↗MalfunctionJan 29, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A DIRTY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24218796 ↗MalfunctionJan 21, 2026No Display/Image
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE DISPLAYED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24134960 ↗MalfunctionJan 7, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT SCOPE/PROBE DEVICE EXHIBITED A FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23996107 ↗MalfunctionJan 7, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, A BLACK IMAGE APPEARED ON THE BRONCHOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989523 ↗MalfunctionJan 6, 2026No Display/Image
THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974217 ↗MalfunctionJan 2, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946794 ↗MalfunctionJan 2, 2026No Display/Image; Optical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE IMAGE WAS BLACK AND THERE WAS NO IMAGE ON THE BRONCHOVIDEOSCOPE DUE TO CIRCUIT BOARD FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944797 ↗MalfunctionDec 27, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
CUSTOMER REPORTED THE DEVICE " HAS A BEND AS WELL IN THE TUBE " . . THE ISSUE WAS FOUND DURING SET UP/PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT. DEVICE INSPECTION FOUND INTERMITTENT/FLICKER IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901434 ↗MalfunctionDec 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THE DISTAL END PLASTIC COVER WAS MISSING PIECES, CHIPPED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858365 ↗MalfunctionDec 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED MISSING DISTAL END COVER GLUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849939 ↗MalfunctionDec 15, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE ON THE SCREEN. THE ISSUE OCCURRED DURING UNPACKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23800159 ↗MalfunctionNov 14, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554598 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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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