Reported Reactions

Devices › Nasopharyngoscope (flexible or rigid)

Device brand name · Rhino-laryngo videoscope

Rhino-Laryngo Videoscope: medical device reports filed with FDA

1,925 reports name it, 2019–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code EOB.

1,925
device reports naming the brand
0% of all MAUDE reports · about 278 a year
1,452
reports, 12 months to August 2026
182 in the 12 months before
99.5%
classified as malfunction
98.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

1,925 medical device reports received by FDA name the brand "Rhino-Laryngo Videoscope" (rhino-laryngo videoscope); the manufacturer given most often on reports is Shirakawa Olympus; received from August 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

1,452 reports arrived in the 12 months to August 2026, up 698% from 182 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 (99.5%) and injury (0.5%); 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 detachment of device or device component (24.3%), failure to clean adequately (15.8%) and device reprocessing problem (9.8%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available and discomfort. 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

0142283Sep 2021: 0Oct 2021: 0Nov 2021: 1Dec 2021: 22022Jan 2022: 0Feb 2022: 4Mar 2022: 0Apr 2022: 4May 2022: 7Jun 2022: 2Jul 2022: 6Aug 2022: 3Sep 2022: 3Oct 2022: 8Nov 2022: 10Dec 2022: 92023Jan 2023: 2Feb 2023: 4Mar 2023: 8Apr 2023: 7May 2023: 6Jun 2023: 14Jul 2023: 8Aug 2023: 17Sep 2023: 10Oct 2023: 12Nov 2023: 10Dec 2023: 182024Jan 2024: 7Feb 2024: 7Mar 2024: 11Apr 2024: 20May 2024: 17Jun 2024: 10Jul 2024: 4Aug 2024: 18Sep 2024: 17Oct 2024: 15Nov 2024: 8Dec 2024: 22025Jan 2025: 3Feb 2025: 9Mar 2025: 7Apr 2025: 8May 2025: 6Jun 2025: 18Jul 2025: 47Aug 2025: 42Sep 2025: 49Oct 2025: 95Nov 2025: 46Dec 2025: 672026Jan 2026: 48Feb 2026: 43Mar 2026: 101Apr 2026: 204May 2026: 177Jun 2026: 126Jul 2026: 213Aug 2026: 283

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

05981,1952019: 620192020: 720202021: 1220212022: 5620222023: 11620232024: 13620242025: 39720252026: 1,1952026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.5%9
Malfunction99.5%1,916
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,925
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
Detachment of device or device componentpart of the device came off46724.3%9%
Failure to clean adequately30415.8%6%
Device reprocessing problem1889.8%3.6%
Peeled/delaminated1739%3.2%
Corrodedthe device corroded1387.2%2.5%
Material fragmentation1316.8%2.3%
Breakthe device broke1055.5%23.8%
Loss of or failure to bond804.2%1.7%
Crackthe device cracked733.8%1.5%
Degraded643.3%1.2%
Material separation583%1.2%
Residue after decontamination542.8%1%
Contamination452.3%1.1%
Material split, cut or torn402.1%1.2%
Poor quality image351.8%1.4%
Material deformation281.5%0.6%
Contamination /decontamination problem221.1%0.4%
Microbial contamination of device211.1%0.4%
Component missing180.9%0.5%
No display/image180.9%10.2%

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.

Patient problems coded

Patient problem (FDA code)ReportsShare
Appropriate clinical signs, symptoms and conditions term/code not available30.2%
Discomfortdiscomfort10.1%

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

In context

MeasureRhino-Laryngo VideoscopeProduct code EOBAll MAUDE reports
Reports1,9258,12726,136,888
Share of that pool—23.7%0%
Classified as death, per 1,000 reports009
Classified as injury0.5%1.3%36.2%
Classified as malfunction99.5%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-Laryngofiberscope3312870%
Visera Rhino-Laryngo Videoscope2831940%
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 Rhino-Laryngo Videoscope reports

How many FDA reports name Rhino-Laryngo Videoscope?

1,925 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,452 in the latest 12 months.

What kinds of events are reported?

malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

detachment of device or device component (24.3%), failure to clean adequately (15.8%), device reprocessing problem (9.8%), peeled/delaminated (9%) and corroded (7.2%). 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 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.