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FDA product code FET · class 2 · Gastroenterology, Urology
Endoscopic video imaging system/component, gastroenterology-urology: medical device reports filed with FDA
62,999 reports carry this product code, 1992–2026; 26 brands with a page.
- 62,999
- reports with this product code
- 0.2% of all MAUDE reports
- 17,540
- reports, 12 months to August 2026
- 13,293 in the 12 months before
- 99.4%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code FET is FDA's classification for "Endoscopic video imaging system/component, gastroenterology-urology" (gastroenterology, Urology panel), a class 2 device. 62,999 medical device reports carry this product code, 0.2% of the MAUDE database, from July 1992 to August 2026.
17,540 reports arrived in the 12 months to August 2026, up 32% from 13,293 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 (0.6%). 26 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Shirakawa Olympus | 50,560 | 80.3% |
| Olympus Medical Systems | 11,335 | 18% |
| Karl Storz Se & Kg | 425 | 0.7% |
| Stryker Endoscopy | 13 | 0% |
| Richard Wolf | 9 | 0% |
| Olympus Winter & Ibe | 4 | 0% |
| Olympus Medical System | 1 | 0% |
| Olympus Optical | 1 | 0% |
| Stryker | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| No display/image | 24,821 | 39.4% |
| Poor quality image | 10,070 | 16% |
| Communication or transmission problemthe device could not communicate or transmit | 8,735 | 13.9% |
| Erratic or intermittent display | 3,330 | 5.3% |
| Breakthe device broke | 2,128 | 3.4% |
| Leak/splashthe device leaked | 2,039 | 3.2% |
| Output problem | 1,862 | 3% |
| Failure to power up | 1,703 | 2.7% |
| Connection problema connection problem | 1,571 | 2.5% |
| Display or visual feedback problem | 1,374 | 2.2% |
| Material split, cut or torn | 1,311 | 2.1% |
| Loose or intermittent connection | 1,247 | 2% |
| Electrical /electronic property probleman electrical or electronic problem | 1,215 | 1.9% |
| Gas/air leak | 1,117 | 1.8% |
| Corrodedthe device corroded | 1,010 | 1.6% |
| Image display error/artifact | 770 | 1.2% |
| Detachment of device or device componentpart of the device came off | 710 | 1.1% |
| Power problem | 570 | 0.9% |
| No device output | 549 | 0.9% |
| Crackthe device cracked | 526 | 0.8% |
Questions about endoscopic video imaging system/component, gastroenterology-urology reports
What is product code FET?
FDA's classification code for "Endoscopic video imaging system/component, gastroenterology-urology", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
62,999 reports through August 2026, 17,540 of them in the latest 12 months.
Which brands appear most often?
Hd Camera Head (8,625), Hd Autoclavable Camera Head (7,331), 4k Camera Head (5,453), High Definition Lcd Monitor (3,523) and Camera Head (3,400). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.