Reported Reactions

Devices › Bronchoscope (flexible or rigid)

Device brand name · Airway mobilescope

Airway Mobilescope: medical device reports filed with FDA

430 reports name it, 2020–2026. Manufacturer given most often on reports: Aizu Olympus. Product code EOQ.

430
device reports naming the brand
0% of all MAUDE reports · about 73 a year
182
reports, 12 months to August 2026
51 in the 12 months before
98.6%
classified as malfunction
86% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 430 reports that name the brand "Airway Mobilescope" (airway mobilescope), received between August 2020 and August 2026; the manufacturer given most often on reports is Aizu Olympus. Spellings of one product vary from report to report.

182 reports arrived in the 12 months to August 2026, up 257% from 51 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 (98.6%) and injury (1.4%); 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 (41.9%), no display/image (11.6%) and degraded (8.1%). The patient problems coded most often are drug resistant bacterial infection, hypoxia and arrhythmia. 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

02141Sep 2021: 2Oct 2021: 3Nov 2021: 3Dec 2021: 52022Jan 2022: 8Feb 2022: 4Mar 2022: 6Apr 2022: 3May 2022: 4Jun 2022: 3Jul 2022: 4Aug 2022: 8Sep 2022: 3Oct 2022: 7Nov 2022: 5Dec 2022: 02023Jan 2023: 5Feb 2023: 3Mar 2023: 4Apr 2023: 9May 2023: 5Jun 2023: 3Jul 2023: 3Aug 2023: 5Sep 2023: 7Oct 2023: 2Nov 2023: 5Dec 2023: 72024Jan 2024: 4Feb 2024: 8Mar 2024: 5Apr 2024: 10May 2024: 6Jun 2024: 6Jul 2024: 9Aug 2024: 3Sep 2024: 9Oct 2024: 7Nov 2024: 2Dec 2024: 42025Jan 2025: 0Feb 2025: 0Mar 2025: 2Apr 2025: 4May 2025: 4Jun 2025: 4Jul 2025: 7Aug 2025: 8Sep 2025: 5Oct 2025: 15Nov 2025: 5Dec 2025: 122026Jan 2026: 9Feb 2026: 13Mar 2026: 41Apr 2026: 13May 2026: 10Jun 2026: 14Jul 2026: 16Aug 2026: 29

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

0731452020: 320202021: 3020212022: 5520222023: 5820232024: 7320242025: 6620252026: 1452026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.4%6
Malfunction98.6%424
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.5%428
Voluntary report0%0
User facility report0%0
Distributor report0.5%2
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/delaminated18041.9%8.7%
No display/image5011.6%23.1%
Degraded358.1%1.9%
Device reprocessing problem337.7%2%
Failure to clean adequately337.7%2.5%
Breakthe device broke307%8.2%
Optical problem174%0.4%
Corrodedthe device corroded122.8%2%
Poor quality image102.3%4.5%
Contamination92.1%0.8%
Erratic or intermittent display92.1%5.1%
Detachment of device or device componentpart of the device came off81.9%4.6%
Dent in material61.4%0.3%
Loss of or failure to bond61.4%0.6%
Display or visual feedback problem51.2%1.5%
Gas/air leak51.2%0.4%
Crackthe device cracked40.9%0.7%
Improper or incorrect procedure or method40.9%0.1%
Leak/splashthe device leaked40.9%0.3%
Material deformation40.9%1%

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
Drug resistant bacterial infection20.5%
Hypoxialow oxygen20.5%
Arrhythmia10.2%
Cardiac arrestthe heart stopped10.2%

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

In context

MeasureAirway MobilescopeProduct code EOQAll MAUDE reports
Reports43032,21226,136,888
Share of that pool—1.3%0%
Classified as death, per 1,000 reports069
Classified as injury1.4%13%36.2%
Classified as malfunction98.6%86%62.3%
Filed by the manufacturer99.5%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%
Evis Lucera Bronchofibervideoscope351710%
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 Airway Mobilescope reports

How many FDA reports name Airway Mobilescope?

430 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 182 in the latest 12 months.

What kinds of events are reported?

malfunction (98.6%) and injury (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

peeled/delaminated (41.9%), no display/image (11.6%), degraded (8.1%), device reprocessing problem (7.7%) and failure to clean adequately (7.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.5%) and distributor reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Airway Mobilescope 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.