Reported Reactions

Devices › Endoscope, accessories, narrow band spectrum

Device brand name · Rigid video laparoscope

Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable: medical device reports filed with FDA

989 reports name it, 2023–2026. Manufacturer given most often on reports: Olympus Winter & Ibe. Product code NWB.

989
device reports naming the brand
0% of all MAUDE reports · about 290 a year
355
reports, 12 months to August 2026
429 in the 12 months before
99.9%
classified as malfunction
98.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

989 medical device reports received by FDA name the brand "Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable" (rigid video laparoscope); the manufacturer given most often on reports is Olympus Winter & Ibe; received from February 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

355 reports arrived in the 12 months to August 2026, down 17% from 429 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 (99.9%) and injury (0.1%); across all endoscope, accessories, narrow band spectrum reports (product code NWB) death is recorded in 0% and malfunction in 98.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are poor quality image (54.3%), no display/image (13.1%) and break (12.2%). 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

03365Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 1Mar 2023: 1Apr 2023: 1May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 1Oct 2023: 1Nov 2023: 1Dec 2023: 22024Jan 2024: 0Feb 2024: 1Mar 2024: 2Apr 2024: 21May 2024: 48Jun 2024: 42Jul 2024: 47Aug 2024: 36Sep 2024: 31Oct 2024: 41Nov 2024: 19Dec 2024: 612025Jan 2025: 41Feb 2025: 37Mar 2025: 48Apr 2025: 40May 2025: 35Jun 2025: 20Jul 2025: 31Aug 2025: 25Sep 2025: 21Oct 2025: 31Nov 2025: 24Dec 2025: 652026Jan 2026: 31Feb 2026: 29Mar 2026: 22Apr 2026: 38May 2026: 31Jun 2026: 16Jul 2026: 19Aug 2026: 28

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

02094182023: 820232024: 34920242025: 41820252026: 2142026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.1%1
Malfunction99.9%988
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%989
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 14,170 reports carrying product code NWB. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Poor quality image53754.3%8.3%
No display/image13013.1%10.5%
Breakthe device broke12112.2%3.7%
Erratic or intermittent display383.8%2.2%
Dent in material333.3%0.4%
Material split, cut or torn333.3%0.3%
Leak/splashthe device leaked313.1%1.3%
Fracturea broken bone303%0.3%
Loose or intermittent connection282.8%1%
Display or visual feedback problem262.6%3.2%
Optical problem212.1%1.7%
Output problem151.5%7.2%
Crackthe device cracked131.3%0.4%
Image display error/artifact111.1%1.1%
Corrodedthe device corroded101%1.1%
Electrical /electronic property probleman electrical or electronic problem90.9%8.1%
Connection problema connection problem80.8%2.3%
Sharp edges80.8%0.1%
Failure to clean adequately70.7%0.9%
Material deformation60.6%0.2%

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

MeasureVideo telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavableProduct code NWBAll MAUDE reports
Reports98914,17026,136,888
Share of that pool—7%0%
Classified as death, per 1,000 reports009
Classified as injury0.1%1.2%36.2%
Classified as malfunction99.9%98.7%62.3%
Filed by the manufacturer100%99.3%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 NWB

BrandReportsLatest 12 monthsClassified as death
Visera Elite Xenon Light Source2,1984780%
Visera 4k Uhd Xenon Light Source2871010%
Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable164640%
Visera Xenon Light Source233280%
Single Use Distal Cover1,0251020%
Visera Elite Video System Center2,6885720%
Visera Cysto-Nephro Videoscope1,7611,1080%
Cysto-Nephro Videoscope5,2833,9060%
VISERA Pro VIDEO SYSTEM CENTER637960%
Halogen Light Source459550%
Visera 4k Uhd Camera Control Unit1,8604250%
Visera Video System Center341730%
Video System Center3,4318380%
VISERA Pro XENON LIGHT SOURCE630700%
4k Autoclavable Camera Head3,0987230%

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 telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable reports

How many FDA reports name Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable?

989 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 355 in the latest 12 months.

What kinds of events are reported?

malfunction (99.9%) and injury (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

poor quality image (54.3%), no display/image (13.1%), break (12.2%), erratic or intermittent display (3.8%) and dent in material (3.3%). 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 telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, 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.