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FDA product code NWB · class 2 · Gastroenterology, Urology

Endoscope, accessories, narrow band spectrum: medical device reports filed with FDA

14,170 reports carry this product code, 2006–2026; 25 brands with a page.

14,170
reports with this product code
0.1% of all MAUDE reports
3,289
reports, 12 months to August 2026
2,705 in the 12 months before
98.7%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

Product code NWB is FDA's classification for "Endoscope, accessories, narrow band spectrum" (gastroenterology, Urology panel), a class 2 device. 14,170 medical device reports carry this product code, 0.1% of the MAUDE database, from April 2006 to August 2026.

3,289 reports arrived in the 12 months to August 2026, up 22% from 2,705 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 (98.7%), injury (1.2%) and other (0.1%). 25 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

BrandReportsLatest 12 monthsClassified as deathClassified as malfunction
Visera Elite Xenon Light Source2,1864780%99.6%
Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable9683550%99.9%
Visera 4k Uhd Xenon Light Source1991010%97.9%
Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable144640%100%
Visera Xenon Light Source111280%98.3%
Single Use Distal Cover311020%58%
Visera Elite Video System Center215720%99.6%
Visera Cysto-Nephro Videoscope141,1080%89.8%
Cysto-Nephro Videoscope103,9060%94.9%
VISERA Pro VIDEO SYSTEM CENTER6960%99.8%
Halogen Light Source5550%100%
Visera 4k Uhd Camera Control Unit54250%99.5%
Visera Video System Center3730%100%
Video System Center28380%99.8%
VISERA Pro XENON LIGHT SOURCE2700%99.8%
4k Autoclavable Camera Head17230%99.7%
Ascensia Contour100.1%89.2%
Disposable Biopsy Forceps180%45.3%
FreeStyle Precision Neo1350%96.9%
Hd Autoclavable Camera Head11,5540%99.9%
Hd Camera Head12,6030%99.9%
Ot Basic Enhanced Meter100%0%
Precision Xtra160.1%92.7%
SINGLE USE BIOPSY VALVE (Sterile)11300%51.2%
Uretero-Reno Videoscope11,8620%96.1%

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)ReportsShare
Shirakawa Olympus9,57467.6%
Olympus Medical Systems3,21722.7%
Olympus Winter & Ibe1,2458.8%
Olympus Medical System330.2%
Olympus Medical Systems Hinode Plant140.1%
Bayer Healthcare40%
Abbott Diabetes Care20%
Lifescan10%

Reports by month, five years

0189378Sep 2021: 124Oct 2021: 93Nov 2021: 113Dec 2021: 1272022Jan 2022: 114Feb 2022: 108Mar 2022: 145Apr 2022: 147May 2022: 130Jun 2022: 173Jul 2022: 166Aug 2022: 169Sep 2022: 169Oct 2022: 166Nov 2022: 160Dec 2022: 1812023Jan 2023: 131Feb 2023: 140Mar 2023: 216Apr 2023: 210May 2023: 160Jun 2023: 173Jul 2023: 167Aug 2023: 227Sep 2023: 174Oct 2023: 200Nov 2023: 187Dec 2023: 1952024Jan 2024: 158Feb 2024: 196Mar 2024: 209Apr 2024: 231May 2024: 239Jun 2024: 205Jul 2024: 256Aug 2024: 274Sep 2024: 248Oct 2024: 267Nov 2024: 133Dec 2024: 2332025Jan 2025: 249Feb 2025: 314Mar 2025: 249Apr 2025: 244May 2025: 173Jun 2025: 169Jul 2025: 204Aug 2025: 222Sep 2025: 185Oct 2025: 378Nov 2025: 238Dec 2025: 2642026Jan 2026: 238Feb 2026: 264Mar 2026: 294Apr 2026: 359May 2026: 313Jun 2026: 234Jul 2026: 271Aug 2026: 251

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

Death0%2
Injury1.2%174
Malfunction98.7%13,980
Other0.1%13
Not given0%1

Who filed

Manufacturer report99.3%14,077
Voluntary report0.3%45
User facility report0%0
Distributor report0.2%26
Not given0.2%22

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)ReportsShare
Communication or transmission problemthe device could not communicate or transmit3,60025.4%
No display/image1,48510.5%
Poor quality image1,1758.3%
Electrical /electronic property probleman electrical or electronic problem1,1518.1%
Output problem1,0227.2%
Failure to power up6734.7%
No device output6214.4%
Breakthe device broke5203.7%
Display or visual feedback problem4533.2%
No visual prompts/feedback4052.9%
Activation failure3982.8%
Connection problema connection problem3262.3%
Erratic or intermittent display3112.2%
Power problem2761.9%
Optical problem2441.7%
Leak/splashthe device leaked1851.3%
Defective component1831.3%
Key or button unresponsive/not working1801.3%
Image display error/artifact1511.1%
Corrodedthe device corroded1491.1%

Questions about endoscope, accessories, narrow band spectrum reports

What is product code NWB?

FDA's classification code for "Endoscope, accessories, narrow band spectrum", 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?

14,170 reports through August 2026, 3,289 of them in the latest 12 months.

Which brands appear most often?

Visera Elite Xenon Light Source (2,186), Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable (968), Visera 4k Uhd Xenon Light Source (199), Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable (144) and Visera Xenon Light Source (111). 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.