Reported Reactions

Devices › Bronchoscope (flexible or rigid)

Device brand name · Bronchovideoscope

Evis Lucera Bronchofibervideoscope: medical device reports filed with FDA

351 reports name it, 2019–2026. Manufacturer given most often on reports: Aizu Olympus. Product code EOQ.

351
device reports naming the brand
0% of all MAUDE reports · about 53 a year
71
reports, 12 months to August 2026
44 in the 12 months before
95.2%
classified as malfunction
86% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

351 medical device reports received by FDA name the brand "Evis Lucera Bronchofibervideoscope" (bronchovideoscope); the manufacturer given most often on reports is Aizu Olympus; received from December 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

71 reports arrived in the 12 months to August 2026, up 61% from 44 in 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 (95.2%) and injury (4.8%); 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 peeled/delaminated (44.7%), break (18.8%) and no display/image (9.1%). The patient problems coded most often are hemorrhage/blood loss/bleeding, pneumothorax and pneumonia. 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

0917Sep 2021: 3Oct 2021: 6Nov 2021: 9Dec 2021: 52022Jan 2022: 9Feb 2022: 9Mar 2022: 3Apr 2022: 8May 2022: 7Jun 2022: 6Jul 2022: 7Aug 2022: 3Sep 2022: 8Oct 2022: 5Nov 2022: 2Dec 2022: 52023Jan 2023: 5Feb 2023: 2Mar 2023: 3Apr 2023: 3May 2023: 3Jun 2023: 7Jul 2023: 4Aug 2023: 5Sep 2023: 11Oct 2023: 6Nov 2023: 7Dec 2023: 42024Jan 2024: 9Feb 2024: 6Mar 2024: 5Apr 2024: 3May 2024: 4Jun 2024: 4Jul 2024: 4Aug 2024: 3Sep 2024: 7Oct 2024: 7Nov 2024: 2Dec 2024: 02025Jan 2025: 2Feb 2025: 2Mar 2025: 0Apr 2025: 5May 2025: 5Jun 2025: 6Jul 2025: 4Aug 2025: 4Sep 2025: 7Oct 2025: 7Nov 2025: 10Dec 2025: 22026Jan 2026: 3Feb 2026: 3Mar 2026: 17Apr 2026: 8May 2026: 1Jun 2026: 2Jul 2026: 4Aug 2026: 7

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

036722019: 620192020: 920202021: 5120212022: 7220222023: 6020232024: 5420242025: 5420252026: 452026

Event type and report source

Event type, as classified on the report

Death0%0
Injury4.8%17
Malfunction95.2%334
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%351
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Peeled/delaminated15744.7%8.7%
Breakthe device broke6618.8%8.2%
No display/image329.1%23.1%
Degraded318.8%1.9%
Poor quality image154.3%4.5%
Erratic or intermittent display113.1%5.1%
Failure to clean adequately92.6%2.5%
Display or visual feedback problem72%1.5%
Detachment of device or device componentpart of the device came off51.4%4.6%
Corrodedthe device corroded41.1%2%
Dent in material30.9%0.3%
Device reprocessing problem30.9%2%
Contamination20.6%0.8%
Device markings/labelling problema problem with the device markings or label20.6%0%
Failure to advance20.6%0.1%
Leak/splashthe device leaked20.6%0.3%
Loss of or failure to bond20.6%0.6%
Material deformation20.6%1%
Microbial contamination of device20.6%2.6%
Scratched material20.6%0.4%

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)ReportsShare
Hemorrhage/blood loss/bleeding51.4%
Pneumothoraxa collapsed lung51.4%
Pneumonialung infection41.1%
Bacterial infectiona bacterial infection20.6%
Respiratory failurethe lungs could not supply enough oxygen20.6%
Asthmaasthma10.3%
Bronchial hemorrhage10.3%
High blood pressure/ hypertension10.3%
Oversedation10.3%
Respiratory tract infectiona respiratory infection10.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureEvis Lucera BronchofibervideoscopeProduct code EOQAll MAUDE reports
Reports35132,21226,136,888
Share of that pool—1.1%0%
Classified as death, per 1,000 reports069
Classified as injury4.8%13%36.2%
Classified as malfunction95.2%86%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Evis Lucera Elite Bronchovideoscope5,8812,3520%
Bronchovideoscope1,9249380.1%
Ion2,6874998.2%
Evis Lucera Bronchovideoscope1,5964070.1%
Tracheal Intubation Fiberscope1,1693240%
Oes Bronchofiberscope4871120%
Airway Mobilescope4301820%
Bronchofiberscope3221260.3%
SINGLE USE BIOPSY VALVE (Sterile)2931300%
Single Use Suction Valve Sterile28200%
Evis Exeraii Bronchovideoscope25200.8%
Evis Exera Bronchovideoscope244344.5%
Visera Tracheal Intubation Videoscope157670%
Halogen Light Source459550%
Olympus2,24092.5%

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 Lucera Bronchofibervideoscope reports

How many FDA reports name Evis Lucera Bronchofibervideoscope?

351 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 71 in the latest 12 months.

What kinds of events are reported?

malfunction (95.2%) and injury (4.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

peeled/delaminated (44.7%), break (18.8%), no display/image (9.1%), degraded (8.8%) and poor quality image (4.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Evis Lucera Bronchofibervideoscope 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.