EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F (UDI 04953170356360)Recalls & reported problems
Olympus Medical Systems Corp. · BF-UC180F ULTRASOUND BRONCHOSCOPE · Class 2
All models of EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE (8)
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 II ultrasound bronchoscope is a flexible scope used in the airways. Many of its 1,070 reports describe no image appearing, parts breaking or coming loose, and poor cleaning, and some mention infections. The reports include 4 deaths and 85 injuries. Two open recalls cover wet scope channels that could lead to infection and a scope that can get stuck in the breathing tube connector.
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
- 1,088
- Deaths reported
- 4
- Injuries reported
- 85
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,088 adverse event reports that list this exact device (DI 04953170356360), received between Jul 13, 2018 and Sep 29, 2026 — classified as 4 deaths, 85 injuries, 999 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (376 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-0328-2024 · 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-2494-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image376
- Detachment of Device or Device Component167
- Device Reprocessing Problem72
- Failure to Clean Adequately72
- Break70
- Poor Quality Image66
- Microbial Contamination of Device55
- Material Fragmentation29
Patient problems
- No Clinical Signs, Symptoms or Conditions993
- Bacterial Infection20
- Fungal Infection19
- No Patient Involvement18
- Foreign Body In Patient8
- Unspecified Infection7
- Insufficient Information6
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 25 most recent of 1,088 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938787 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
The customer reported the device was contaminated after use during reprocessing involving an Olympus Ultrasonic Bronchofibervideoscope. There was no patient injury reported. Despite good faith attempts additional information was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933474 ↗MalfunctionSep 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926395 ↗MalfunctionSep 28, 2026Crack
The customer returned the ultrasonic bronchofibervideoscope to the service center for a separate issue. During the device analysis, it was indicated that a chip at the distal end pink rubber was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921629 ↗MalfunctionSep 28, 2026No Display/Image; Failure to Clean Adequately
The customer reported blackish gray discharge during reprocessing involving an Olympus ultrasonic bronchofibervideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920778 ↗MalfunctionSep 24, 2026Erratic or Intermittent Display
The customer returned the Ultrasonic Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, an intermittent-flickering image observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887587 ↗MalfunctionSep 23, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873547 ↗MalfunctionSep 23, 2026Degraded
The customer returned the BRONCHOFIBERVIDEOSCOPE to the service center for evaluation related to a separate issue. During testing, it was identified that the distal end channel outlet was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870250 ↗MalfunctionSep 22, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858842 ↗MalfunctionSep 22, 2026Crack; Sharp Edges
The customer returned the Bronchofibervideoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that a reportable malfunction was found. It was determined that the distal end had cuts at the channel opening pink rubber had chips. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854030 ↗MalfunctionSep 16, 2026Crack
The videoscope, an Olympus asset with no reported complaint, was returned by the customer. During evaluation of the device, a small chip in the pink rubber was observed on the Bronchofiberscope. No patient involvement was associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792850 ↗MalfunctionSep 16, 2026Material Fragmentation; Image Display Error/Artifact; Peeled/Delaminated
The customer returned the Bronchofibervideoscope for another issue. During evaluation of the device, it was noted that there was chipping of the c-body at the channel outlet and the image was flickering. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789264 ↗MalfunctionSep 15, 2026Material Fragmentation; Scratched Material
The customer returned the Ultrasonic Bronchofibervideoscope to the service center for a separate issue. During the device analysis, the Service Engineer indicated that deep scratches and a chip in the channel opening were found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776900 ↗MalfunctionSep 14, 2026Material Fragmentation
The customer returned the Ultrasonic Bronchofibervideoscope to the service center for a separate issue. During the initial device analysis, the Olympus Service Repair Technician indicated that there was a small chip on the Pink Probe. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752875 ↗MalfunctionSep 10, 2026Break; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721745 ↗MalfunctionSep 10, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715837 ↗MalfunctionSep 9, 2026Break; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695261 ↗MalfunctionSep 9, 2026Break; No Display/Image; Image Display Error/Artifact
The customer reported that the camera is not turning on, involving an Olympus bronchofibervideoscope. The inspection found that the image was distorted and the pink rubber had a tiny chip at the distal end. The issue was found during preparation for use and before the patient was in the room. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690515 ↗MalfunctionSep 8, 2026No Display/Image
The customer reported the lighting works but there is no image, it was all back during set up/ inspection for use involving an Olympus ultrasonic broncho fiber videoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675055 ↗MalfunctionSep 2, 2026Erratic or Intermittent Display; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571903 ↗MalfunctionAug 31, 2026No Display/Image
An Olympus Field Service Engineer (FSE) reported that during an onsite inspection of the ultrasonic bronchofibervideoscope there was no image displayed. The FSE suspects that this was due to an electrical/electronic component problem. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525397 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50522603 ↗MalfunctionAug 29, 2026No Display/Image; Communication or Transmission Problem; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509958 ↗MalfunctionAug 28, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502170 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
The customer reported the distal white piece has broken off the end of scope during set up/ inspection for use involving an Olympus ultrasonic bronchofibervideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487159 ↗
Other Ultrasound bronchoscope devices
- EVES EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UC190FOlympus Medical Systems Corp. · Ultrasound bronchoscope2 recalls1,082 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope35 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope18 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope8 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FOlympus Medical Systems Corp. · Ultrasound bronchoscope4 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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