Devices › Gastroscope and accessories, flexible/rigid
Device brand name · Gastrointestinal videoscope
Evis Exera Gastrointestinal Videoscope: medical device reports filed with FDA
354 reports name it, 2016–2026. Manufacturer given most often on reports: Aizu Olympus. Product code FDS.
- 354
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 64
- reports, 12 months to August 2026
- 37 in the 12 months before
- 96.9%
- classified as malfunction
- 98.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
354 medical device reports received by FDA name the brand "Evis Exera Gastrointestinal Videoscope" (gastrointestinal videoscope); the manufacturer given most often on reports is Aizu Olympus; received from July 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
64 reports arrived in the 12 months to August 2026, up 73% from 37 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 (96.9%) and injury (3.1%); across all gastroscope and accessories, flexible/rigid reports (product code FDS) death is recorded in 0.1% and malfunction in 98.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are microbial contamination of device (34.2%), failure to clean adequately (24.3%) and device reprocessing problem (12.7%). The patient problems coded most often are hemorrhage/blood loss/bleeding, perforation and drug resistant bacterial infection. 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 76,761 reports carrying product code FDS. 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 |
|---|---|---|---|
| Microbial contamination of device | 121 | 34.2% | 4% |
| Failure to clean adequately | 86 | 24.3% | 29.5% |
| Device reprocessing problem | 45 | 12.7% | 7.6% |
| Poor quality image | 41 | 11.6% | 11.2% |
| Contamination | 10 | 2.8% | 1.5% |
| No display/image | 9 | 2.5% | 7.8% |
| Image display error/artifact | 8 | 2.3% | 1.1% |
| Erratic or intermittent display | 7 | 2% | 5.7% |
| Contamination /decontamination problem | 6 | 1.7% | 0.9% |
| Device contamination with chemical or other material | 5 | 1.4% | 0.7% |
| Overheating of device | 5 | 1.4% | 0.9% |
| Melted | 4 | 1.1% | 1.2% |
| Display or visual feedback problem | 3 | 0.8% | 0.4% |
| Residue after decontamination | 3 | 0.8% | 5.6% |
| Crackthe device cracked | 2 | 0.6% | 0.6% |
| Difficult or delayed positioning | 2 | 0.6% | 0.1% |
| Material too rigid or stiff | 2 | 0.6% | 0.1% |
| Physical resistance/sticking | 2 | 0.6% | 0.2% |
| Breakthe device broke | 1 | 0.3% | 3.5% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.3% | 8% |
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 | 2 | 0.6% |
| Perforation | 2 | 0.6% |
| Drug resistant bacterial infection | 1 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.3% |
| Inflammationinflammation | 1 | 0.3% |
| Laceration(s) | 1 | 0.3% |
| No patient involvement | 1 | 0.3% |
| Transmissible spongiform encephalopathy(tse) | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evis Exera Gastrointestinal Videoscope | Product code FDS | All MAUDE reports |
|---|---|---|---|
| Reports | 354 | 76,761 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 3.1% | 1.4% | 36.2% |
| Classified as malfunction | 96.9% | 98.4% | 62.3% |
| Filed by the manufacturer | 99.7% | 99.7% | 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 FDS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Evis Lucera Elite Gastrointestinal Videoscope | 17,900 | 11,247 | 0% |
| Gastrointestinal Videoscope | 13,634 | 8,589 | 0% |
| Pentax | 47,288 | 2,443 | 0.1% |
| Evis Lucera Gastrointestinal Videoscope | 6,041 | 2,491 | 0.2% |
| EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE | 1,282 | 674 | 0% |
| PENTAX Medical | 1,349 | 807 | 0.3% |
| Disposable Distal Attachment | 184 | 24 | 0% |
| Imagina | 263 | 0 | 0% |
| Halogen Light Source | 459 | 55 | 0% |
| Olympus | 2,240 | 9 | 2.5% |
| Balloon | 330 | 48 | 0.3% |
| Video System | 558 | 73 | 0% |
| SINGLE USE BIOPSY VALVE (Sterile) | 293 | 130 | 0% |
| Ultrasonic Gastrovideoscope | 1,885 | 902 | 0.2% |
| Colonovideoscope | 9,419 | 5,712 | 0% |
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 Exera Gastrointestinal Videoscope reports
How many FDA reports name Evis Exera Gastrointestinal Videoscope?
354 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 64 in the latest 12 months.
What kinds of events are reported?
malfunction (96.9%) and injury (3.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
microbial contamination of device (34.2%), failure to clean adequately (24.3%), device reprocessing problem (12.7%), poor quality image (11.6%) and contamination (2.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and distributor reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Evis Exera Gastrointestinal Videoscope 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.