Devices › Colonoscope and accessories, flexible/rigid
Device brand name · Colonovideoscope
Evis Lucera Elite Colonovideoscope: medical device reports filed with FDA
16,369 reports name it, 2018–2026. Manufacturer given most often on reports: Aizu Olympus. Product code FDF.
- 16,369
- device reports naming the brand
- 0.1% of all MAUDE reports · about 1,985 a year
- 9,695
- reports, 12 months to August 2026
- 2,170 in the 12 months before
- 99.4%
- classified as malfunction
- 98.1% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 16,369 reports that name the brand "Evis Lucera Elite Colonovideoscope" (colonovideoscope), received between April 2018 and August 2026; the manufacturer given most often on reports is Aizu Olympus. Spellings of one product vary from report to report.
9,695 reports arrived in the 12 months to August 2026, up 347% from 2,170 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 (99.4%) and injury (0.5%); across all colonoscope and accessories, flexible/rigid reports (product code FDF) death is recorded in 0.1% and malfunction in 98.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to clean adequately (33.1%), communication or transmission problem (19.1%) and poor quality image (12.1%). The patient problems coded most often are hemorrhage/blood loss/bleeding, perforation 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 81,401 reports carrying product code FDF. 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 |
|---|---|---|---|
| Failure to clean adequately | 5,410 | 33.1% | 28.5% |
| Communication or transmission problemthe device could not communicate or transmit | 3,131 | 19.1% | 9.9% |
| Poor quality image | 1,980 | 12.1% | 6.2% |
| No display/image | 1,924 | 11.8% | 10.4% |
| Erratic or intermittent display | 1,123 | 6.9% | 5.8% |
| Device reprocessing problem | 749 | 4.6% | 6.3% |
| Residue after decontamination | 718 | 4.4% | 3% |
| Corrodedthe device corroded | 499 | 3% | 1.6% |
| Display or visual feedback problem | 292 | 1.8% | 0.7% |
| Contamination | 267 | 1.6% | 1.5% |
| Microbial contamination of device | 217 | 1.3% | 6.2% |
| Image display error/artifact | 212 | 1.3% | 0.6% |
| Melted | 168 | 1% | 0.5% |
| Thermal decomposition of device | 150 | 0.9% | 0.5% |
| Overheating of device | 136 | 0.8% | 0.6% |
| Device contamination with chemical or other material | 132 | 0.8% | 0.4% |
| Contamination /decontamination problem | 120 | 0.7% | 0.7% |
| Flare or flash | 84 | 0.5% | 0.2% |
| Output problem | 70 | 0.4% | 0.3% |
| Degraded | 66 | 0.4% | 0.2% |
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 | 38 | 0.2% |
| Perforation | 18 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 12 | 0.1% |
| Bowel perforation | 12 | 0.1% |
| Abdominal painstomach or belly pain | 7 | 0% |
| Foreign body in patientpart of a device left in the patient | 5 | 0% |
| Gastrointestinal hemorrhage | 4 | 0% |
| Chemical exposure | 3 | 0% |
| Cholangitis | 2 | 0% |
| Hyperemia | 2 | 0% |
| Laceration(s) | 2 | 0% |
| Swelling/ edema | 2 | 0% |
| Transmissible spongiform encephalopathy(tse) | 2 | 0% |
| Ulcer | 2 | 0% |
| Bradycardiaslow heart rate | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evis Lucera Elite Colonovideoscope | Product code FDF | All MAUDE reports |
|---|---|---|---|
| Reports | 16,369 | 81,401 | 26,136,888 |
| Share of that pool | — | 20.1% | 0.1% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 0.5% | 1.7% | 36.2% |
| Classified as malfunction | 99.4% | 98.1% | 62.3% |
| Filed by the manufacturer | 100% | 99.4% | 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 FDF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pentax | 47,288 | 2,443 | 0.1% |
| Colonovideoscope | 9,419 | 5,712 | 0% |
| Evis Lucera Colonovideoscope | 2,171 | 1,019 | 0% |
| Evis Exera Lll Colonovideoscope | 1,052 | 0 | 0.2% |
| PENTAX Medical | 1,349 | 807 | 0.3% |
| Olympus | 2,240 | 9 | 2.5% |
| Evis Lusera Colonovideoscope | 411 | 31 | 0% |
| Maintenance Unit | 419 | 76 | 0% |
| Video System Center | 3,431 | 838 | 0% |
| Imagina | 263 | 0 | 0% |
| CRE Wireguided | 718 | 56 | 0.3% |
| Ultrasonic Gastrovideoscope | 1,885 | 902 | 0.2% |
| Visera Video System Center | 341 | 73 | 0% |
| Ultrasonic Probe | 787 | 212 | 0.5% |
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 Elite Colonovideoscope reports
How many FDA reports name Evis Lucera Elite Colonovideoscope?
16,369 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9,695 in the latest 12 months.
What kinds of events are reported?
malfunction (99.4%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to clean adequately (33.1%), communication or transmission problem (19.1%), poor quality image (12.1%), no display/image (11.8%) and erratic or intermittent display (6.9%). 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 Evis Lucera Elite Colonovideoscope 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.