Devices › Bronchoscope (flexible or rigid)
Device brand name · Bronchofiberscope
Oes Bronchofiberscope: medical device reports filed with FDA
487 reports name it, 2015–2026. Manufacturer given most often on reports: Aizu Olympus. Product code EOQ.
- 487
- device reports naming the brand
- 0% of all MAUDE reports · about 43 a year
- 112
- reports, 12 months to August 2026
- 71 in the 12 months before
- 92.2%
- classified as malfunction
- 86% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
487 medical device reports received by FDA name the brand "Oes Bronchofiberscope" (bronchofiberscope); the manufacturer given most often on reports is Aizu Olympus; received from March 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
112 reports arrived in the 12 months to August 2026, up 58% from 71 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 (92.2%) and injury (7.8%); 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 (36.1%), break (11.9%) and degraded (9.2%). The patient problems coded most often are fungal infection, pneumothorax and appropriate clinical signs, symptoms and conditions term/code not available. 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 |
|---|---|---|---|
| Peeled/delaminated | 176 | 36.1% | 8.7% |
| Breakthe device broke | 58 | 11.9% | 8.2% |
| Degraded | 45 | 9.2% | 1.9% |
| Microbial contamination of device | 43 | 8.8% | 2.6% |
| Failure to clean adequately | 24 | 4.9% | 2.5% |
| Device reprocessing problem | 19 | 3.9% | 2% |
| Detachment of device or device componentpart of the device came off | 17 | 3.5% | 4.6% |
| Thermal decomposition of device | 12 | 2.5% | 3.7% |
| Contamination /decontamination problem | 11 | 2.3% | 0.5% |
| Loss of or failure to bond | 10 | 2.1% | 0.6% |
| Material deformation | 8 | 1.6% | 1% |
| Corrodedthe device corroded | 7 | 1.4% | 2% |
| No display/image | 6 | 1.2% | 23.1% |
| Contamination | 5 | 1% | 0.8% |
| Overheating of device | 5 | 1% | 0.6% |
| Poor quality image | 4 | 0.8% | 4.5% |
| Residue after decontamination | 4 | 0.8% | 0.3% |
| Crackthe device cracked | 3 | 0.6% | 0.7% |
| Gas/air leak | 3 | 0.6% | 0.4% |
| Mechanical jam | 3 | 0.6% | 0.1% |
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) | Reports | Share |
|---|---|---|
| Fungal infectiona fungal infection | 17 | 3.5% |
| Pneumothoraxa collapsed lung | 5 | 1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.6% |
| No patient involvement | 3 | 0.6% |
| Drug resistant bacterial infection | 2 | 0.4% |
| Fever | 2 | 0.4% |
| Hemorrhage/blood loss/bleeding | 2 | 0.4% |
| Cardiac arrestthe heart stopped | 1 | 0.2% |
| Dyspneashortness of breath | 1 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.2% |
| Hemoptysis | 1 | 0.2% |
| Hypoxialow oxygen | 1 | 0.2% |
| Respiratory failurethe lungs could not supply enough oxygen | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Oes Bronchofiberscope | Product code EOQ | All MAUDE reports |
|---|---|---|---|
| Reports | 487 | 32,212 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 7.8% | 13% | 36.2% |
| Classified as malfunction | 92.2% | 86% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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% |
| Evis Exera Bronchovideoscope | 244 | 34 | 4.5% |
| 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 Oes Bronchofiberscope reports
How many FDA reports name Oes Bronchofiberscope?
487 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 112 in the latest 12 months.
What kinds of events are reported?
malfunction (92.2%) and injury (7.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
peeled/delaminated (36.1%), break (11.9%), degraded (9.2%), microbial contamination of device (8.8%) and failure to clean adequately (4.9%). 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 Oes Bronchofiberscope 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.