Reported Reactions

Devices › Nasopharyngoscope (flexible or rigid)

Device brand name · Rhino-laryngofiberscope

Rhino-Laryngo Fiberscope: medical device reports filed with FDA

267 reports name it, 2020–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code EOB.

267
device reports naming the brand
0% of all MAUDE reports · about 45 a year
145
reports, 12 months to August 2026
53 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 267 reports that name the brand "Rhino-Laryngo Fiberscope" (rhino-laryngofiberscope), received between July 2020 and August 2026; the manufacturer given most often on reports is Shirakawa Olympus. Spellings of one product vary from report to report.

145 reports arrived in the 12 months to August 2026, up 174% from 53 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 detachment of device or device component (21.3%), failure to clean adequately (19.9%) and break (6.4%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available. 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

01734Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 1Mar 2022: 0Apr 2022: 0May 2022: 2Jun 2022: 1Jul 2022: 0Aug 2022: 0Sep 2022: 1Oct 2022: 2Nov 2022: 0Dec 2022: 12023Jan 2023: 2Feb 2023: 3Mar 2023: 2Apr 2023: 1May 2023: 0Jun 2023: 0Jul 2023: 2Aug 2023: 4Sep 2023: 5Oct 2023: 4Nov 2023: 1Dec 2023: 22024Jan 2024: 4Feb 2024: 2Mar 2024: 3Apr 2024: 6May 2024: 2Jun 2024: 3Jul 2024: 2Aug 2024: 3Sep 2024: 2Oct 2024: 6Nov 2024: 2Dec 2024: 02025Jan 2025: 3Feb 2025: 4Mar 2025: 2Apr 2025: 1May 2025: 2Jun 2025: 4Jul 2025: 7Aug 2025: 20Sep 2025: 13Oct 2025: 34Nov 2025: 7Dec 2025: 52026Jan 2026: 2Feb 2026: 3Mar 2026: 9Apr 2026: 12May 2026: 19Jun 2026: 8Jul 2026: 15Aug 2026: 18

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

0511022020: 420202021: 620212022: 820222023: 2620232024: 3520242025: 10220252026: 862026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.4%1
Malfunction99.6%266
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%267
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 off5721.3%9%
Failure to clean adequately5319.9%6%
Breakthe device broke176.4%23.8%
Device reprocessing problem176.4%3.6%
Peeled/delaminated155.6%3.2%
Material separation134.9%1.2%
Poor quality image114.1%1.4%
Contamination103.7%1.1%
Corrodedthe device corroded103.7%2.5%
Loss of or failure to bond103.7%1.7%
Material fragmentation103.7%2.3%
Component missing62.2%0.5%
Degraded62.2%1.2%
Residue after decontamination62.2%1%
No display/image51.9%10.2%
Material split, cut or torn41.5%1.2%
Mechanical problema mechanical problem41.5%0.3%
Contamination /decontamination problem31.1%0.4%
Crackthe device cracked31.1%1.5%
Material deformation20.7%0.6%

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 available20.7%

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

In context

MeasureRhino-Laryngo FiberscopeProduct code EOBAll MAUDE reports
Reports2678,12726,136,888
Share of that pool—3.3%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%
Visera Rhino-Laryngo Videoscope2831940%
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 Fiberscope reports

How many FDA reports name Rhino-Laryngo Fiberscope?

267 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 145 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?

detachment of device or device component (21.3%), failure to clean adequately (19.9%), break (6.4%), device reprocessing problem (6.4%) and peeled/delaminated (5.6%). 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 Rhino-Laryngo Fiberscope 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.