EVIS EXERA BRONCHOFIBERVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one EVIS EXERA BRONCHOFIBERVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 2
We found 5 models of EVIS EXERA BRONCHOFIBERVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2020 and Apr 14, 2026 — classified as 8 injuries, 43 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (22 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EVIS EXERA BRONCHOFIBERVIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 27, 2023Open, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2491-2023 · Root cause: Labeling Change Control · names 5 of these models · Recall details · FDA record ↗
- Mar 8, 2022Open, Classified
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Z-1048-2022 · Root cause: Other · Recall details · FDA record ↗
Most reported EVIS EXERA BRONCHOFIBERVIDEOSCOPE problems
Device problems
- No Display/Image22
- Poor Quality Image6
- Communication or Transmission Problem3
- Peeled/Delaminated3
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Contamination /Decontamination Problem2
- Device Reprocessing Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Low Oxygen Saturation2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
- Unspecified Infection1
- Viral Infection1
EVIS EXERA BRONCHOFIBERVIDEOSCOPE models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE MP160FBRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls3 reports
- EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160FBRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall43 reports
- EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160FBRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall3 reports
- EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE MP160FBRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall2 reports
- EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160FBRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
Recent EVIS EXERA BRONCHOFIBERVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Crack
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF IMAGE WITH SCRATCH. 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, CHIPPED OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872920 ↗MalfunctionMar 17, 2026Device Reprocessing Problem; Human-Device Interface Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE HAD A STICKY UNIVERSAL CORD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24624465 ↗MalfunctionFeb 18, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385200 ↗MalfunctionJan 5, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE IMAGE WAS DARK AND THERE WAS A LINE ACROSS THE IMAGE OF THE BRONCHOFIBERVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956538 ↗MalfunctionDec 22, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED A FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873618 ↗MalfunctionDec 17, 2025Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image
CUSTOMER REPORTED " MINOR ENDOSCOPE LEAK ". THE ISSUE WAS FOUND DURING REPROCESSING. DEVICE INSPECTION FOUND IMAGE-NOISY, GRAINY. THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825724 ↗MalfunctionDec 16, 2025No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED NO IMAGE (BLACK IMAGE). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824397 ↗MalfunctionAug 19, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED A NOISY IMAGE DUE TO A DAMAGED CHARGED COUPLE DEVICE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843565 ↗MalfunctionJun 20, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED HAD FOREIGN MATERIAL IN THE BENDING RUBBER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22297603 ↗MalfunctionAug 22, 2024No Display/Image; No Display/Image
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE BROCHOVIDEOSCOPE EXHIBITED NO IMAGE-UNRESTORABLE, NO ERROR CODE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20038863 ↗MalfunctionJul 10, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE BRONCHOFIBERVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19712016 ↗InjuryJun 10, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A BRONCHOSCOPIC PROCEDURE (ON A 3-YEAR-OLD PATIENT WEIGHING 16.4 KILOGRAMS), THE BRONCHOVIDEOSCOPE PRODUCED A COMPLETE BLACKOUT AND NO IMAGE COULD BE PRODUCED. THE EVENT OCCURRED DURING PREPARATION FOR USE WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE WAS DELAYED BY 30 MINUTES AND COMPLETED BY REPLACING WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505685 ↗InjuryJun 5, 2024No Display/Image; No Display/Image
IT WAS REPORTED FOR A BRONCHOFIBERVIDEOSCOPE, THE IMAGE DID NOT APPEAR AND THERE WAS A COMPLETE BLACK OUT OF THE SCREEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19466562 ↗MalfunctionApr 30, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE OF THE BRONCHOFIBERVIDEOSCOPE WAS NOT CLEAR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19215807 ↗MalfunctionFeb 5, 2024No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18645862 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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