Device brand name · Rigid endoscope telescope
Telescope "OES ELITE", 4 mm, 12, HD, autoclavable: medical device reports filed with FDA
507 reports name it, 2022–2026. Manufacturer given most often on reports: Olympus Winter & Ibe. Product code FGC.
- 507
- device reports naming the brand
- 0% of all MAUDE reports · about 142 a year
- 112
- reports, 12 months to August 2026
- 199 in the 12 months before
- 100%
- classified as malfunction
- 99.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
507 medical device reports received by FDA name the brand "Telescope "OES ELITE", 4 mm, 12, HD, autoclavable" (rigid endoscope telescope); the manufacturer given most often on reports is Olympus Winter & Ibe; received from December 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
112 reports arrived in the 12 months to August 2026, down 44% from 199 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 (100%); across all urethroscope reports (product code FGC) death is recorded in 0% and malfunction in 99.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (51.9%), detachment of device or device component (17.9%) and loose or intermittent connection (7.3%). 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 1,768 reports carrying product code FGC. 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 |
|---|---|---|---|
| Breakthe device broke | 263 | 51.9% | 55.8% |
| Detachment of device or device componentpart of the device came off | 91 | 17.9% | 16.8% |
| Loose or intermittent connection | 37 | 7.3% | 6.1% |
| Crackthe device cracked | 30 | 5.9% | 7.2% |
| Component missing | 14 | 2.8% | 2.2% |
| Poor quality image | 13 | 2.6% | 2.7% |
| Fracturea broken bone | 12 | 2.4% | 0.8% |
| Degraded | 9 | 1.8% | 0.8% |
| Material integrity problema problem with the device material | 5 | 1% | 0.9% |
| Mechanical problema mechanical problem | 5 | 1% | 1.1% |
| Melted | 5 | 1% | 0.3% |
| Unstable | 5 | 1% | 2.6% |
| Defective component | 4 | 0.8% | 0.4% |
| Failure to align | 4 | 0.8% | 0.3% |
| Material deformation | 4 | 0.8% | 0.6% |
| Material separation | 4 | 0.8% | 1% |
| Material fragmentation | 3 | 0.6% | 1.3% |
| Material twisted/bent | 3 | 0.6% | 1.1% |
| Optical problem | 3 | 0.6% | 0.5% |
| Overheating of device | 3 | 0.6% | 0.5% |
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 | Telescope "OES ELITE", 4 mm, 12, HD, autoclavable | Product code FGC | All MAUDE reports |
|---|---|---|---|
| Reports | 507 | 1,768 | 26,136,888 |
| Share of that pool | — | 28.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0.4% | 36.2% |
| Classified as malfunction | 100% | 99.6% | 62.3% |
| Filed by the manufacturer | 100% | 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 FGC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Telescope "OES ELITE", 4 mm, 30, HD, autoclavable | 870 | 219 | 0% |
| Telescope "OES ELITE", 4 mm, 70, HD, autoclavable | 350 | 187 | 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 Telescope "OES ELITE", 4 mm, 12, HD, autoclavable reports
How many FDA reports name Telescope "OES ELITE", 4 mm, 12, HD, autoclavable?
507 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 112 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (51.9%), detachment of device or device component (17.9%), loose or intermittent connection (7.3%), crack (5.9%) and component missing (2.8%). 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 Telescope "OES ELITE", 4 mm, 12, HD, autoclavable 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.