Device brand name · Rigid video laparoscope
Video-Optik "ENDOEYE 3D", 30: medical device reports filed with FDA
1,204 reports name it, 2024–2026. Manufacturer given most often on reports: Olympus Winter & Ibe. Product code GCM.
- 1,204
- device reports naming the brand
- 0% of all MAUDE reports · about 483 a year
- 541
- reports, 12 months to August 2026
- 480 in the 12 months before
- 99.8%
- classified as malfunction
- 99.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,204 medical device reports received by FDA name the brand "Video-Optik "ENDOEYE 3D", 30" (rigid video laparoscope); the manufacturer given most often on reports is Olympus Winter & Ibe; received from January 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
541 reports arrived in the 12 months to August 2026, up 13% from 480 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 (99.8%) and injury (0.2%); across all endoscope, rigid reports (product code GCM) death is recorded in 0.1% and malfunction in 99.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are poor quality image (49.4%), no display/image (13.8%) and break (10.4%). 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 1,538 reports carrying product code GCM. 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 |
|---|---|---|---|
| Poor quality image | 595 | 49.4% | 46.7% |
| No display/image | 166 | 13.8% | 12.5% |
| Breakthe device broke | 125 | 10.4% | 11.2% |
| Communication or transmission problemthe device could not communicate or transmit | 102 | 8.5% | 8.5% |
| Dent in material | 44 | 3.7% | 3.8% |
| Erratic or intermittent display | 41 | 3.4% | 3% |
| Output problem | 41 | 3.4% | 2.9% |
| Optical problem | 36 | 3% | 3% |
| Scratched material | 33 | 2.7% | 2.9% |
| Failure to clean adequately | 31 | 2.6% | 3.2% |
| Material split, cut or torn | 28 | 2.3% | 2.7% |
| Display or visual feedback problem | 27 | 2.2% | 2.7% |
| Loose or intermittent connection | 23 | 1.9% | 1.8% |
| Image orientation incorrect | 22 | 1.8% | 1.4% |
| Fracturea broken bone | 21 | 1.7% | 1.8% |
| Sharp edges | 21 | 1.7% | 1.7% |
| Image display error/artifact | 19 | 1.6% | 1.8% |
| Crackthe device cracked | 16 | 1.3% | 1.6% |
| Leak/splashthe device leaked | 15 | 1.2% | 1.4% |
| Degraded | 12 | 1% | 1% |
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.
In context
| Measure | Video-Optik "ENDOEYE 3D", 30 | Product code GCM | All MAUDE reports |
|---|---|---|---|
| Reports | 1,204 | 1,538 | 26,136,888 |
| Share of that pool | — | 78.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 0.2% | 0.8% | 36.2% |
| Classified as malfunction | 99.8% | 99.1% | 62.3% |
| Filed by the manufacturer | 100% | 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 GCM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Video telescope "ENDOEYE 3D", 10 mm, 0 | 293 | 132 | 0% |
| Hd Epscp 4 0 30 167 Mitek | 575 | 27 | 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 Video-Optik "ENDOEYE 3D", 30 reports
How many FDA reports name Video-Optik "ENDOEYE 3D", 30?
1,204 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 541 in the latest 12 months.
What kinds of events are reported?
malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
poor quality image (49.4%), no display/image (13.8%), break (10.4%), communication or transmission problem (8.5%) and dent in material (3.7%). 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 Video-Optik "ENDOEYE 3D", 30 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.