Devices › Mediastinoscope, surgical
Device brand name · Rigid optical laparoscope
Telescope, 10 mm, 30, HD, quick lock, autoclavable: medical device reports filed with FDA
248 reports name it, 2022–2026. Manufacturer given most often on reports: Olympus Winter & Ibe. Product code EWY.
- 248
- device reports naming the brand
- 0% of all MAUDE reports · about 69 a year
- 46
- reports, 12 months to August 2026
- 77 in the 12 months before
- 100%
- classified as malfunction
- 93.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 248 reports that name the brand "Telescope, 10 mm, 30, HD, quick lock, autoclavable" (rigid optical laparoscope), received between December 2022 and August 2026; the manufacturer given most often on reports is Olympus Winter & Ibe. Spellings of one product vary from report to report.
46 reports arrived in the 12 months to August 2026, down 40% from 77 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 mediastinoscope, surgical reports (product code EWY) death is recorded in 0% and malfunction in 93.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (50.8%), detachment of device or device component (21%) and crack (6%). 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 366 reports carrying product code EWY. 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 | 126 | 50.8% | 47% |
| Detachment of device or device componentpart of the device came off | 52 | 21% | 19.9% |
| Crackthe device cracked | 15 | 6% | 4.9% |
| Loose or intermittent connection | 14 | 5.6% | 4.1% |
| Component missing | 9 | 3.6% | 4.1% |
| Poor quality image | 7 | 2.8% | 2.2% |
| Mechanical problema mechanical problem | 6 | 2.4% | 1.6% |
| Material integrity problema problem with the device material | 5 | 2% | 1.9% |
| Material separation | 4 | 1.6% | 2.2% |
| Degraded | 3 | 1.2% | 0.8% |
| Material deformation | 2 | 0.8% | 0.8% |
| Naturally worn | 2 | 0.8% | 0.8% |
| Unintended movement | 2 | 0.8% | 0.3% |
| Connection problema connection problem | 1 | 0.4% | 0.3% |
| Defective component | 1 | 0.4% | 0.5% |
| Disconnection | 1 | 0.4% | 0.3% |
| Failure to clean adequately | 1 | 0.4% | 0.3% |
| Loss of or failure to bond | 1 | 0.4% | 0.3% |
| Material split, cut or torn | 1 | 0.4% | 0.5% |
| Missing information | 1 | 0.4% | 0% |
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, 10 mm, 30, HD, quick lock, autoclavable | Product code EWY | All MAUDE reports |
|---|---|---|---|
| Reports | 248 | 366 | 26,136,888 |
| Share of that pool | — | 67.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 6.3% | 36.2% |
| Classified as malfunction | 100% | 93.4% | 62.3% |
| Filed by the manufacturer | 100% | 98.6% | 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."
Questions about Telescope, 10 mm, 30, HD, quick lock, autoclavable reports
How many FDA reports name Telescope, 10 mm, 30, HD, quick lock, autoclavable?
248 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 46 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 (50.8%), detachment of device or device component (21%), crack (6%), loose or intermittent connection (5.6%) and component missing (3.6%). 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, 10 mm, 30, HD, quick lock, 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.