Devices › Endoscopic video imaging system/component, gastroenterology-urology
Device brand name · Video system center
Evis X1 Video System Center: medical device reports filed with FDA
1,424 reports name it, 2021–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code FET.
- 1,424
- device reports naming the brand
- 0% of all MAUDE reports · about 267 a year
- 858
- reports, 12 months to August 2026
- 304 in the 12 months before
- 98.1%
- classified as malfunction
- 99.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,424 medical device reports received by FDA name the brand "Evis X1 Video System Center" (video system center); the manufacturer given most often on reports is Shirakawa Olympus; received from March 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
858 reports arrived in the 12 months to August 2026, up 182% from 304 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 (98.1%) and injury (1.9%); across all endoscopic video imaging system/component, gastroenterology-urology reports (product code FET) death is recorded in 0% and malfunction in 99.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no display/image (67%), poor quality image (10.4%) and erratic or intermittent display (6.2%). The patient problems coded most often are pneumothorax, appropriate clinical signs, symptoms and conditions term/code not available and bowel perforation. 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 62,999 reports carrying product code FET. 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 |
|---|---|---|---|
| No display/image | 954 | 67% | 39.4% |
| Poor quality image | 148 | 10.4% | 16% |
| Erratic or intermittent display | 88 | 6.2% | 5.3% |
| Leak/splashthe device leaked | 63 | 4.4% | 3.2% |
| Communication or transmission problemthe device could not communicate or transmit | 52 | 3.7% | 13.9% |
| Output problem | 30 | 2.1% | 3% |
| Moisture damage | 26 | 1.8% | 0.1% |
| Corrodedthe device corroded | 21 | 1.5% | 1.6% |
| Display or visual feedback problem | 17 | 1.2% | 2.2% |
| Image display error/artifact | 16 | 1.1% | 1.2% |
| Failure to power up | 12 | 0.8% | 2.7% |
| Moisture or humidity problem | 9 | 0.6% | 0.1% |
| Breakthe device broke | 7 | 0.5% | 3.4% |
| Circuit failure | 7 | 0.5% | 0.5% |
| Failure to clean adequately | 7 | 0.5% | 0.4% |
| Free or unrestricted flow | 7 | 0.5% | 0% |
| Gas/air leak | 7 | 0.5% | 1.8% |
| No device output | 7 | 0.5% | 0.9% |
| Connection problema connection problem | 6 | 0.4% | 2.5% |
| Degraded | 5 | 0.4% | 0.3% |
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 |
|---|---|---|
| Pneumothoraxa collapsed lung | 7 | 0.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.2% |
| Bowel perforation | 2 | 0.1% |
| Hemorrhage/blood loss/bleeding | 2 | 0.1% |
| Laceration(s) | 2 | 0.1% |
| Pneumoperitoneum | 2 | 0.1% |
| Pulmonary emphysema | 2 | 0.1% |
| Respiratory failurethe lungs could not supply enough oxygen | 2 | 0.1% |
| Apnea | 1 | 0.1% |
| Confusion/ disorientation | 1 | 0.1% |
| Dysphasia | 1 | 0.1% |
| Headachehead pain | 1 | 0.1% |
| Neck painneck pain | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evis X1 Video System Center | Product code FET | All MAUDE reports |
|---|---|---|---|
| Reports | 1,424 | 62,999 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 1.9% | 0.6% | 36.2% |
| Classified as malfunction | 98.1% | 99.4% | 62.3% |
| Filed by the manufacturer | 99.7% | 99.8% | 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 FET
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Hd Camera Head | 8,629 | 2,603 | 0% |
| Hd Autoclavable Camera Head | 7,648 | 1,554 | 0% |
| 4k Camera Head | 5,453 | 1,701 | 0% |
| High Definition Lcd Monitor | 3,553 | 565 | 0% |
| Camera Head | 3,771 | 948 | 0% |
| 4k Autoclavable Camera Head | 3,098 | 723 | 0% |
| Video System Center | 3,431 | 838 | 0% |
| Visera Elite Video System Center | 2,688 | 572 | 0% |
| Hd 3cmos Autoclavable Camera Head | 2,118 | 727 | 0% |
| Visera 4k Uhd Camera Control Unit | 1,860 | 425 | 0% |
| Hd 3cmos Camera Head | 1,502 | 572 | 0% |
| Evis Lucera Elite Video System Center | 1,347 | 554 | 0% |
| VISERA Pro VIDEO SYSTEM CENTER | 637 | 96 | 0% |
| Video System | 558 | 73 | 0% |
| Visera Video System Center | 341 | 73 | 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 X1 Video System Center reports
How many FDA reports name Evis X1 Video System Center?
1,424 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 858 in the latest 12 months.
What kinds of events are reported?
malfunction (98.1%) and injury (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no display/image (67%), poor quality image (10.4%), erratic or intermittent display (6.2%), leak/splash (4.4%) and communication or transmission problem (3.7%). 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 X1 Video System Center 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.