EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160Recalls & reported problems
Olympus Medical Systems Corp. · BF-XT160 VIDEOSCOPE 6.2MM DIA 3.2MM CH · Class 2
All models of EVIS EXERA BRONCHOVIDEOSCOPE (3)
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 BF-XT160 bronchoscope has 41 adverse event reports, mentioning one death and seven injuries. Reports mostly describe display failures and melted or burned distal covers, sometimes with microbial contamination. There are four open recalls about IFU updates for laser, argon plasma, or high-frequency use, unvalidated channel drying, scope size, and endobronchial combustion. Reports fell from 10 to 1 in the last 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
- 41
- Deaths reported
- 1
- Injuries reported
- 7
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 04953170340147), received between Aug 29, 2018 and Jan 8, 2026 — classified as 1 death, 7 injuries, 33 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (13 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-0065-2026 · Root cause: Device Design · Recall details · FDA record ↗
- 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-2490-2023 · 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-2014-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image13
- Microbial Contamination of Device11
- Thermal Decomposition of Device9
- Material Split, Cut or Torn7
- Peeled/Delaminated4
- Melted2
- Device Reprocessing Problem1
- Failure to Clean Adequately1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Known Impact Or Consequence To Patient5
- Bacterial Infection4
- Chills1
- Death1
- Fever1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026No Display/Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THERE WAS NO IMAGE ON THE BRONCHOVIDEOSCOPE WHEN PLUGGED INTO THE LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003224 ↗MalfunctionJul 22, 2025Overheating of Device; Overheating of Device
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566403 ↗MalfunctionMay 12, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD IMAGE INTERFERENCE OCCUR WHERE THE BRONCHIAL IMAGE DISAPPEARED AND A BLACK SCREEN WITH ¿WHITE STRIPES¿ APPEARED. THERE WERE NO REPORTS OF PATIENT HARM. THE ISSUE OCCURRED WHILE PERFORMING THE BRONCHOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004032 ↗MalfunctionDec 3, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
DURING THE 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 20835620 ↗MalfunctionNov 18, 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 20707792 ↗MalfunctionNov 14, 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 20692024 ↗MalfunctionNov 12, 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 20664261 ↗MalfunctionNov 11, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER HAD BURNED/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 20652234 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
DURING THE 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 20646452 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED/MELTED 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 20642284 ↗MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED/MELTED 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 20642245 ↗MalfunctionAug 6, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE IMAGE IS BLACK. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917092 ↗MalfunctionJul 9, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE; THE SCREEN IS BLACK. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19704893 ↗MalfunctionJun 14, 2024Material Deformation; Material Deformation
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED A BURNT PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19543225 ↗InjuryMay 13, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE DID NOT HAVE AN IMAGE AT THE BEGINNING OF NAVIGATIONAL BRONCHOSCOPY AFTER INSERTING THE SCOPE DOWN THE PATIENT'S ENDOTRACHEAL TUBE. THE CAMERA STARTED TO HAVE ISSUES AND THE DOCTOR COULD NOT SEE THE PATIENT'S ANATOMY RESULTING IN A FORTY MINUTE DELAY WHILE UNDER GENERAL ANESTHESIA. THERE WAS AN ERROR MESSAGE, N207 PRESENT. THE NAVIGATIONAL BRONCHOSCOPY WAS NOT COMPLETED AND THE PATIENT WAS NOT HARMED DUE TO THE REPORTED EVENT. THEY THEN PROCEEDED WITH THE SECOND PROCEDURE, A ENDOBRONCHIAL ULTRASOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19306951 ↗MalfunctionMay 8, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE ONLY DISPLAYED STRIPES ON THE IMAGE. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19272276 ↗InjuryApr 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE DID NOT HAVE AN IMAGE AT THE BEGINNING OF NAVIGATIONAL BRONCHOSCOPY AFTER INSERTING THE SCOPE DOWN THE PATIENT'S ENDOTRACHEAL TUBE. THE CAMERA STARTED TO HAVE ISSUES AND THE DOCTOR COULD NOT SEE THE PATIENT'S ANATOMY RESULTING IN A FORTY MINUTE DELAY WHILE UNDER GENERAL ANESTHESIA. THERE WAS AN ERROR MESSAGE, N207 PRESENT. THE NAVIGATIONAL BRONCHOSCOPY WAS NOT COMPLETED AND THE PATIENT WAS NOT HARMED DUE TO THE REPORTED EVENT. THEY THEN PROCEEDED WITH THE SECOND PROCEDURE, A ENDOBRONCHIAL ULTRASOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19164504 ↗MalfunctionApr 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE CAMERA OF THE BRONCHOVIDEOSCOPE WASN¿T WORKING PROPERLY, IT KEPT GOING IN AND OUT AND THE PICTURE WENT BLACK. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19086713 ↗MalfunctionApr 2, 2024Melted; Melted
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED THE DISTAL END PLASTIC COVER BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19026329 ↗MalfunctionMar 6, 2024Peeled/Delaminated; Failure to Clean Adequately; Peeled/Delaminated; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHO-VIDEOSCOPE EXHIBITED THAT THE COATING HAD PEELING ON THE CONNECTING TUBE, AND THE DISTAL END HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18843735 ↗MalfunctionDec 21, 2023No Display/Image; No Display/Image
A USER FACILITY RETURNED THE OLYMPUS ASSET, BRONCHOVIDEOSCOPE, TO THE OLYMPUS SERVICE CENTER WITH A DESCRIPTION OF "BROKEN". UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE WAS NO IMAGE (BLACK). THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18380202 ↗MalfunctionNov 13, 2023Melted; Melted
THE CUSTOMER REPORTED THAT THEY COULD NOT REPROCESS THEIR EVIS EXERA BRONCHOVIDEOSCOPE DEVICE DUE TO UNSPECIFIED REASONS. UPON THE RECEIPT AND INSPECTION OF THE RETURNED DEVICE ON 14OCT2023, IT WAS DISCOVERED THAT THE PLASTIC DISTAL END COVER WAS BURNED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18126964 ↗MalfunctionAug 2, 2023No Display/Image; No Display/Image
THE CUSTOMER REPORTED THAT HIS OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE WASN¿T DISPLAYING AN IMAGE DURING PROCEDURE PREPARATION. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO ERROR MESSAGES PRESENT AND THE ROOM WAS GIVEN A NEW SCOPE TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17442298 ↗MalfunctionApr 27, 2023No Display/Image; No Display/Image
THE CUSTOMER'S REPORTED PROBLEM OCCURRED DURING AN UNSPECIFIED PROCEDURE, THE LENGTH OF WHICH WAS UNKNOWN, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DEATH, INJURY, OR INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16828517 ↗MalfunctionApr 7, 2023Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE EVIS EXERA BRONCHOVIDEOSCOPE, A DISTAL END DEFECT WAS OBSERVED. THE PROCEDURE WAS ALVEOLAR BRONCHOLAVAGE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. DURING TESTING AND INSPECTION OF THE RETURNED DEVICE, THE COATING ON THE INSERTION SECTION WAS FOUND TO BE PEELING OFF (GREATER THAN OR EQUAL TO 1 X 1 MM2), WHICH HAD BEEN ATTRIBUTED DUE TO STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16702460 ↗
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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