Reported Reactions

Devices › Bronchoscope (flexible or rigid)

Device brand name · Single use suction valve

Single Use Suction Valve Sterile: medical device reports filed with FDA

282 reports name it, 2019–2024. Manufacturer given most often on reports: Olympus Medical Systems. Product code EOQ.

282
device reports naming the brand
0% of all MAUDE reports · about 38 a year
0
reports, 12 months to August 2026
2 in the 12 months before
98.2%
classified as malfunction
86% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 282 reports that name the brand "Single Use Suction Valve Sterile" (single use suction valve), received between January 2019 and November 2024; the manufacturer given most often on reports is Olympus Medical Systems. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 2 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 (98.2%) and injury (1.8%); across all bronchoscope (flexible or rigid) reports (product code EOQ) death is recorded in 0.6% and malfunction in 86%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (94.7%), detachment of device or device component (1.1%) and difficult to remove (0.4%). The patient problems coded most often are exposure to body fluids and injury. 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

012Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 2Sep 2022: 0Oct 2022: 0Nov 2022: 1Dec 2022: 02023Jan 2023: 1Feb 2023: 1Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 1Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 1Feb 2024: 0Mar 2024: 0Apr 2024: 1May 2024: 1Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 1Oct 2024: 0Nov 2024: 1Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

01252502019: 25020192020: 2120202022: 320222023: 320232024: 52024

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.8%5
Malfunction98.2%277
Other0%0
Not given0%0

Who filed the report

Manufacturer report98.6%278
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given1.4%4

Grey bar: all 32,212 reports carrying product code EOQ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke26794.7%8.2%
Detachment of device or device componentpart of the device came off31.1%4.6%
Difficult to removethe device was hard to remove10.4%0.2%
Entrapment of device10.4%0.1%
Fitting problem10.4%0%
Loose or intermittent connection10.4%0.9%
Suction problem10.4%0.1%
Unintended ejection10.4%0%

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
Exposure to body fluids10.4%
Injurya physical injury10.4%

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

In context

MeasureSingle Use Suction Valve SterileProduct code EOQAll MAUDE reports
Reports28232,21226,136,888
Share of that pool—0.9%0%
Classified as death, per 1,000 reports069
Classified as injury1.8%13%36.2%
Classified as malfunction98.2%86%62.3%
Filed by the manufacturer98.6%97.8%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 EOQ

BrandReportsLatest 12 monthsClassified as death
Evis Lucera Elite Bronchovideoscope5,8812,3520%
Bronchovideoscope1,9249380.1%
Ion2,6874998.2%
Evis Lucera Bronchovideoscope1,5964070.1%
Tracheal Intubation Fiberscope1,1693240%
Oes Bronchofiberscope4871120%
Airway Mobilescope4301820%
Evis Lucera Bronchofibervideoscope351710%
Bronchofiberscope3221260.3%
SINGLE USE BIOPSY VALVE (Sterile)2931300%
Evis Exeraii Bronchovideoscope25200.8%
Evis Exera Bronchovideoscope244344.5%
Visera Tracheal Intubation Videoscope157670%
Halogen Light Source459550%
Olympus2,24092.5%

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 Single Use Suction Valve Sterile reports

How many FDA reports name Single Use Suction Valve Sterile?

282 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (98.2%) and injury (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (94.7%), detachment of device or device component (1.1%), difficult to remove (0.4%), entrapment of device (0.4%) and fitting problem (0.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Single Use Suction Valve Sterile 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.