Devices › Endoscopic ultrasound system, gastroenterology-urology
Device brand name · Ultrasound gastrovideoscope
Evis Lucera Ultrasound Gastrovideoscope: medical device reports filed with FDA
2,499 reports name it, 2018–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code ODG.
- 2,499
- device reports naming the brand
- 0% of all MAUDE reports · about 312 a year
- 1,387
- reports, 12 months to August 2026
- 297 in the 12 months before
- 97%
- classified as malfunction
- 97.9% across the product code
- 0.2%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 2,499 reports that name the brand "Evis Lucera Ultrasound Gastrovideoscope" (ultrasound gastrovideoscope), received between July 2018 and August 2026; the manufacturer given most often on reports is Shirakawa Olympus. Spellings of one product vary from report to report.
1,387 reports arrived in the 12 months to August 2026, up 367% from 297 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 (97%), injury (2.9%) and death (0.2%); across all endoscopic ultrasound system, gastroenterology-urology reports (product code ODG) death is recorded in 0.2% and malfunction in 97.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are peeled/delaminated (21.2%), failure to clean adequately (20.6%) and break (10.7%). The patient problems coded most often are hemorrhage/blood loss/bleeding, pancreatitis and peritonitis. 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 17,021 reports carrying product code ODG. 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 | 529 | 21.2% | 13.9% |
| Failure to clean adequately | 516 | 20.6% | 8% |
| Breakthe device broke | 267 | 10.7% | 8.8% |
| No display/image | 199 | 8% | 4.5% |
| Residue after decontamination | 190 | 7.6% | 1.8% |
| Crackthe device cracked | 188 | 7.5% | 8.3% |
| Detachment of device or device componentpart of the device came off | 179 | 7.2% | 17.6% |
| Corrodedthe device corroded | 165 | 6.6% | 1.9% |
| Device reprocessing problem | 133 | 5.3% | 3.1% |
| Degraded | 89 | 3.6% | 4.4% |
| Material split, cut or torn | 83 | 3.3% | 14.1% |
| Material separation | 80 | 3.2% | 5.2% |
| Poor quality image | 77 | 3.1% | 1.2% |
| Scratched material | 66 | 2.6% | 2.1% |
| Microbial contamination of device | 54 | 2.2% | 6.1% |
| Loss of or failure to bond | 49 | 2% | 1.2% |
| Material puncture/hole | 43 | 1.7% | 3.6% |
| Material fragmentation | 42 | 1.7% | 1.7% |
| Material deformation | 37 | 1.5% | 1.4% |
| Contamination | 28 | 1.1% | 1.4% |
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) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 24 | 1% |
| Pancreatitisinflammation of the pancreas | 19 | 0.8% |
| Peritonitis | 18 | 0.7% |
| Cholangitis | 9 | 0.4% |
| Perforation | 7 | 0.3% |
| Abscessa collection of pus | 5 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 0.2% |
| Biliary leak | 5 | 0.2% |
| Abdominal painstomach or belly pain | 3 | 0.1% |
| Aspiration pneumonitis | 3 | 0.1% |
| Fungal infectiona fungal infection | 3 | 0.1% |
| Pseudoaneurysm | 3 | 0.1% |
| Fever | 2 | 0.1% |
| Gastrointestinal hemorrhage | 2 | 0.1% |
| Sepsisa severe body-wide response to infection | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evis Lucera Ultrasound Gastrovideoscope | Product code ODG | All MAUDE reports |
|---|---|---|---|
| Reports | 2,499 | 17,021 | 26,136,888 |
| Share of that pool | — | 14.7% | 0% |
| Classified as death, per 1,000 reports | 2 | 2 | 9 |
| Classified as injury | 2.9% | 1.9% | 36.2% |
| Classified as malfunction | 97% | 97.9% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 ODG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ultrasonic Gastrovideoscope | 1,885 | 902 | 0.2% |
| Evis Eus Ultrasound Gastrointestinal Videoscope | 297 | 159 | 0% |
| 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 Lucera Ultrasound Gastrovideoscope reports
How many FDA reports name Evis Lucera Ultrasound Gastrovideoscope?
2,499 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,387 in the latest 12 months.
What kinds of events are reported?
malfunction (97%), injury (2.9%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
peeled/delaminated (21.2%), failure to clean adequately (20.6%), break (10.7%), no display/image (8%) and residue after decontamination (7.6%). 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 Ultrasound Gastrovideoscope 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.