Devices › Ultrasound bronchoscope
Device brand name · Bronchofibervideoscope
Evis Eus Ultrasound Bronchofibervideoscope: medical device reports filed with FDA
3,471 reports name it, 2020–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code PSV.
- 3,471
- device reports naming the brand
- 0% of all MAUDE reports · about 556 a year
- 2,405
- reports, 12 months to August 2026
- 527 in the 12 months before
- 96.6%
- classified as malfunction
- 93.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 3,471 reports that name the brand "Evis Eus Ultrasound Bronchofibervideoscope" (bronchofibervideoscope), received between April 2020 and August 2026; the manufacturer given most often on reports is Shirakawa Olympus. Spellings of one product vary from report to report.
2,405 reports arrived in the 12 months to August 2026, up 356% from 527 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 (96.6%) and injury (3.4%); across all ultrasound bronchoscope reports (product code PSV) death is recorded in 0.1% and malfunction in 93.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (27.2%), no display/image (18.2%) and communication or transmission problem (10.8%). The patient problems coded most often are foreign body in patient, subclinical infection 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 6,336 reports carrying product code PSV. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 945 | 27.2% | 23.1% |
| No display/image | 630 | 18.2% | 20.1% |
| Communication or transmission problemthe device could not communicate or transmit | 374 | 10.8% | 6.7% |
| Failure to clean adequately | 326 | 9.4% | 8.2% |
| Poor quality image | 236 | 6.8% | 6.2% |
| Material fragmentation | 220 | 6.3% | 5.1% |
| Device reprocessing problem | 183 | 5.3% | 4.8% |
| Breakthe device broke | 166 | 4.8% | 6% |
| Corrodedthe device corroded | 149 | 4.3% | 3.8% |
| Peeled/delaminated | 127 | 3.7% | 4.1% |
| Crackthe device cracked | 92 | 2.7% | 1.7% |
| Loss of or failure to bond | 70 | 2% | 1.5% |
| Material separation | 69 | 2% | 2% |
| Microbial contamination of device | 57 | 1.6% | 2.7% |
| Material split, cut or torn | 55 | 1.6% | 1.9% |
| Degraded | 52 | 1.5% | 1.2% |
| Contamination | 47 | 1.4% | 1.4% |
| Erratic or intermittent display | 41 | 1.2% | 1.5% |
| Image display error/artifact | 40 | 1.2% | 0.8% |
| Display or visual feedback problem | 39 | 1.1% | 1.1% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 12 | 0.3% |
| Subclinical infection | 12 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 0.1% |
| Hemorrhage/blood loss/bleeding | 3 | 0.1% |
| Hypoxialow oxygen | 2 | 0.1% |
| Pneumonialung infection | 2 | 0.1% |
| Pneumothoraxa collapsed lung | 2 | 0.1% |
| Pulmonary emphysema | 2 | 0.1% |
| Upper respiratory tract injury | 2 | 0.1% |
| Abscessa collection of pus | 1 | 0% |
| Bacterial infectiona bacterial infection | 1 | 0% |
| Chest painchest pain | 1 | 0% |
| Decreased respiratory rate | 1 | 0% |
| Fever | 1 | 0% |
| Gastrointestinal hemorrhage | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evis Eus Ultrasound Bronchofibervideoscope | Product code PSV | All MAUDE reports |
|---|---|---|---|
| Reports | 3,471 | 6,336 | 26,136,888 |
| Share of that pool | — | 54.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 3.4% | 6% | 36.2% |
| Classified as malfunction | 96.6% | 93.9% | 62.3% |
| Filed by the manufacturer | 98.7% | 98.2% | 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 PSV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Evis Lucera Ultrasonic Bronchofibervideoscope | 745 | 393 | 0.3% |
| Balloon | 330 | 48 | 0.3% |
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 Eus Ultrasound Bronchofibervideoscope reports
How many FDA reports name Evis Eus Ultrasound Bronchofibervideoscope?
3,471 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2,405 in the latest 12 months.
What kinds of events are reported?
malfunction (96.6%) and injury (3.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (27.2%), no display/image (18.2%), communication or transmission problem (10.8%), failure to clean adequately (9.4%) and poor quality image (6.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%) and distributor reports (1.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Evis Eus Ultrasound 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.