Reported Reactions

Devices › Nasopharyngoscope (flexible or rigid)

Device brand name · Rhino-laryngo videoscope

Visera Rhino-Laryngo Videoscope: medical device reports filed with FDA

283 reports name it, 2019–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code EOB.

283
device reports naming the brand
0% of all MAUDE reports · about 39 a year
194
reports, 12 months to August 2026
33 in the 12 months before
99.6%
classified as malfunction
98.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 283 reports that name the brand "Visera Rhino-Laryngo Videoscope" (rhino-laryngo videoscope), received between April 2019 and August 2026; the manufacturer given most often on reports is Shirakawa Olympus. Spellings of one product vary from report to report.

194 reports arrived in the 12 months to August 2026, up 488% from 33 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 (99.6%) and injury (0.4%); across all nasopharyngoscope (flexible or rigid) reports (product code EOB) death is recorded in 0% and malfunction in 98.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to clean adequately (18%), detachment of device or device component (17.3%) and device reprocessing problem (12.4%). The patient problems coded most often are transmissible spongiform encephalopathy(tse). 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

02142Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 1May 2022: 0Jun 2022: 1Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 2Nov 2022: 1Dec 2022: 32023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 1May 2023: 2Jun 2023: 0Jul 2023: 0Aug 2023: 1Sep 2023: 6Oct 2023: 3Nov 2023: 0Dec 2023: 22024Jan 2024: 0Feb 2024: 0Mar 2024: 2Apr 2024: 0May 2024: 1Jun 2024: 0Jul 2024: 2Aug 2024: 23Sep 2024: 3Oct 2024: 3Nov 2024: 2Dec 2024: 02025Jan 2025: 0Feb 2025: 1Mar 2025: 3Apr 2025: 4May 2025: 0Jun 2025: 3Jul 2025: 8Aug 2025: 6Sep 2025: 5Oct 2025: 11Nov 2025: 3Dec 2025: 42026Jan 2026: 5Feb 2026: 7Mar 2026: 6Apr 2026: 31May 2026: 30Jun 2026: 20Jul 2026: 30Aug 2026: 42

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

0861712019: 520192022: 820222023: 1520232024: 3620242025: 4820252026: 1712026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.4%1
Malfunction99.6%282
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%283
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 8,127 reports carrying product code EOB. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to clean adequately5118%6%
Detachment of device or device componentpart of the device came off4917.3%9%
Device reprocessing problem3512.4%3.6%
Peeled/delaminated3412%3.2%
Corrodedthe device corroded279.5%2.5%
Breakthe device broke238.1%23.8%
Loss of or failure to bond238.1%1.7%
Material fragmentation186.4%2.3%
Material separation93.2%1.2%
Residue after decontamination93.2%1%
Degraded72.5%1.2%
Material split, cut or torn62.1%1.2%
Contamination41.4%1.1%
Poor quality image41.4%1.4%
Crackthe device cracked31.1%1.5%
Device contaminated at the user facility20.7%0.1%
Fracturea broken bone20.7%0.4%
Melted20.7%0%
Positioning failure20.7%0.1%
Component missing10.4%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.

Patient problems coded

Patient problem (FDA code)ReportsShare
Transmissible spongiform encephalopathy(tse)10.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureVisera Rhino-Laryngo VideoscopeProduct code EOBAll MAUDE reports
Reports2838,12726,136,888
Share of that pool—3.5%0%
Classified as death, per 1,000 reports009
Classified as injury0.4%1.3%36.2%
Classified as malfunction99.6%98.6%62.3%
Filed by the manufacturer100%99.4%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 EOB

BrandReportsLatest 12 monthsClassified as death
Pentax47,2882,4430.1%
Rhino-Laryngo Videoscope1,9251,4520%
Rhino-Laryngofiberscope3312870%
Rhino-Laryngo Fiberscope2671450%
PENTAX Medical1,3498070.3%
Videoarthroscope Hd 4mm X 30 Deg17900%
4k C-Mnt Scp 4 0 30 167 Mitek5412050%
Endoeye Flex Deflectable Videoscope8,0622,2450%
Bronchovideoscope1,9249380.1%
Single Use Suction Valve Sterile28200%
Disposable Biopsy Forceps20180%
Hd Epscp 4 0 30 167 Mitek575270%
SINGLE USE BIOPSY VALVE (Sterile)2931300%
VISERA Pro VIDEO SYSTEM CENTER637960%

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 Visera Rhino-Laryngo Videoscope reports

How many FDA reports name Visera Rhino-Laryngo Videoscope?

283 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 194 in the latest 12 months.

What kinds of events are reported?

malfunction (99.6%) and injury (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to clean adequately (18%), detachment of device or device component (17.3%), device reprocessing problem (12.4%), peeled/delaminated (12%) and corroded (9.5%). 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 Visera Rhino-Laryngo Videoscope 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.