Devices › Bronchoscope (flexible or rigid)
Device brand name · Bronchovideoscope
Evis Exera Bronchovideoscope: medical device reports filed with FDA
244 reports name it, 2014–2026. Manufacturer given most often on reports: Aizu Olympus. Product code EOQ.
- 244
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 34
- reports, 12 months to August 2026
- 37 in the 12 months before
- 66%
- classified as malfunction
- 86% across the product code
- 4.5%
- classified as death, as reported
- 11 reports · not verified by FDA
FDA's MAUDE database holds 244 reports that name the brand "Evis Exera Bronchovideoscope" (bronchovideoscope), received between February 2014 and August 2026; the manufacturer given most often on reports is Aizu Olympus. Spellings of one product vary from report to report.
34 reports arrived in the 12 months to August 2026, close to the 37 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (66%), injury (29.5%) and death (4.5%); across all bronchoscope (flexible or rigid) reports (product code EOQ) death is recorded in 0.6% and malfunction in 86%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no display/image (23.4%), microbial contamination of device (13.5%) and break (7.8%). The patient problems coded most often are bacterial infection, death and foreign body in patient. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 32,212 reports carrying product code EOQ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| No display/image | 57 | 23.4% | 23.1% |
| Microbial contamination of device | 33 | 13.5% | 2.6% |
| Breakthe device broke | 19 | 7.8% | 8.2% |
| Device disinfection or sterilization issue | 14 | 5.7% | 0.1% |
| Poor quality image | 11 | 4.5% | 4.5% |
| Loose or intermittent connection | 9 | 3.7% | 0.9% |
| Thermal decomposition of device | 9 | 3.7% | 3.7% |
| Overheating of device | 8 | 3.3% | 0.6% |
| Detachment of device or device componentpart of the device came off | 7 | 2.9% | 4.6% |
| Device reprocessing problem | 7 | 2.9% | 2% |
| Erratic or intermittent display | 7 | 2.9% | 5.1% |
| Material split, cut or torn | 7 | 2.9% | 1% |
| Failure to clean adequately | 5 | 2% | 2.5% |
| Peeled/delaminated | 5 | 2% | 8.7% |
| Contamination | 4 | 1.6% | 0.8% |
| Corrodedthe device corroded | 4 | 1.6% | 2% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 1.2% | 10.7% |
| Crackthe device cracked | 3 | 1.2% | 0.7% |
| Insufficient device problem information | 3 | 1.2% | 0.5% |
| Display or visual feedback problem | 2 | 0.8% | 1.5% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Bacterial infectiona bacterial infection | 32 | 13.1% |
| Deaththe patient died; cause not stated by this term | 11 | 4.5% |
| Foreign body in patientpart of a device left in the patient | 4 | 1.6% |
| Pneumothoraxa collapsed lung | 4 | 1.6% |
| No patient involvement | 3 | 1.2% |
| Hemorrhage/blood loss/bleeding | 2 | 0.8% |
| Pneumonialung infection | 2 | 0.8% |
| Respiratory failurethe lungs could not supply enough oxygen | 2 | 0.8% |
| Viral infectiona viral infection | 2 | 0.8% |
| Injurya physical injury | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evis Exera Bronchovideoscope | Product code EOQ | All MAUDE reports |
|---|---|---|---|
| Reports | 244 | 32,212 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 45 | 6 | 9 |
| Classified as injury | 29.5% | 13% | 36.2% |
| Classified as malfunction | 66% | 86% | 62.3% |
| Filed by the manufacturer | 97.1% | 97.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code EOQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Evis Lucera Elite Bronchovideoscope | 5,881 | 2,352 | 0% |
| Bronchovideoscope | 1,924 | 938 | 0.1% |
| Ion | 2,687 | 499 | 8.2% |
| Evis Lucera Bronchovideoscope | 1,596 | 407 | 0.1% |
| Tracheal Intubation Fiberscope | 1,169 | 324 | 0% |
| Oes Bronchofiberscope | 487 | 112 | 0% |
| Airway Mobilescope | 430 | 182 | 0% |
| Evis Lucera Bronchofibervideoscope | 351 | 71 | 0% |
| Bronchofiberscope | 322 | 126 | 0.3% |
| SINGLE USE BIOPSY VALVE (Sterile) | 293 | 130 | 0% |
| Single Use Suction Valve Sterile | 282 | 0 | 0% |
| Evis Exeraii Bronchovideoscope | 252 | 0 | 0.8% |
| Visera Tracheal Intubation Videoscope | 157 | 67 | 0% |
| Halogen Light Source | 459 | 55 | 0% |
| Olympus | 2,240 | 9 | 2.5% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Evis Exera Bronchovideoscope reports
How many FDA reports name Evis Exera Bronchovideoscope?
244 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 34 in the latest 12 months.
What kinds of events are reported?
malfunction (66%), injury (29.5%) and death (4.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no display/image (23.4%), microbial contamination of device (13.5%), break (7.8%), device disinfection or sterilization issue (5.7%) and poor quality image (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.1%), distributor reports (1.6%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Evis Exera Bronchovideoscope was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.