Reported Reactions

Devices › Device types

FDA product code MNL · class 1 · Gastroenterology, Urology

Accessories, cleaning brushes, for endoscope: medical device reports filed with FDA

674 reports carry this product code, 1998–2026; 3 brands with a page.

674
reports with this product code
0% of all MAUDE reports
115
reports, 12 months to August 2026
117 in the 12 months before
94.7%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

Product code MNL is FDA's classification for "Accessories, cleaning brushes, for endoscope" (gastroenterology, Urology panel), a class 1 device. 674 medical device reports carry this product code, 0% of the MAUDE database, from January 1998 to August 2026.

115 reports arrived in the 12 months to August 2026, close to the 117 of 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 (94.7%), injury (5%) and other (0.1%). 3 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
HedgeHog251410%97.6%
6 Shooter Saeed Multi-Band Ligator1920.1%89.4%
Verify180%43.9%

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
Cook Ireland223.3%
Boston Scientific - Marlborough172.5%
Hoya Pentax Tokyo Office101.5%
Olympus Medical Systems Hinode Plant10.1%

Reports by month, five years

01325Sep 2021: 4Oct 2021: 1Nov 2021: 5Dec 2021: 32022Jan 2022: 9Feb 2022: 2Mar 2022: 0Apr 2022: 3May 2022: 4Jun 2022: 15Jul 2022: 0Aug 2022: 6Sep 2022: 5Oct 2022: 5Nov 2022: 8Dec 2022: 32023Jan 2023: 4Feb 2023: 3Mar 2023: 7Apr 2023: 1May 2023: 7Jun 2023: 4Jul 2023: 2Aug 2023: 5Sep 2023: 10Oct 2023: 6Nov 2023: 6Dec 2023: 102024Jan 2024: 3Feb 2024: 5Mar 2024: 6Apr 2024: 9May 2024: 1Jun 2024: 13Jul 2024: 4Aug 2024: 5Sep 2024: 4Oct 2024: 12Nov 2024: 0Dec 2024: 42025Jan 2025: 9Feb 2025: 7Mar 2025: 25Apr 2025: 10May 2025: 15Jun 2025: 15Jul 2025: 10Aug 2025: 6Sep 2025: 9Oct 2025: 20Nov 2025: 4Dec 2025: 122026Jan 2026: 7Feb 2026: 10Mar 2026: 4Apr 2026: 16May 2026: 15Jun 2026: 2Jul 2026: 6Aug 2026: 10

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%0
Injury5%34
Malfunction94.7%638
Other0.1%1
Not given0.1%1

Who filed

Manufacturer report92.6%624
Voluntary report4.3%29
User facility report0%0
Distributor report0%0
Not given3.1%21

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

Device problems coded

Device problem (FDA code)ReportsShare
Breakthe device broke34751.5%
Detachment of device or device componentpart of the device came off497.3%
Detachment of device component375.5%
Material separation243.6%
Entrapment of device233.4%
Difficult to removethe device was hard to remove223.3%
Fracturea broken bone213.1%
Material integrity problema problem with the device material203%
Device reprocessing problem162.4%
Failure to clean adequately162.4%
Device contaminated during manufacture or shipping152.2%
Material fragmentation121.8%
Defective devicethe device was defective91.3%
Failure to disconnect81.2%
Suction problem71%
Device contamination with chemical or other material60.9%
Difficult to insertthe device was hard to insert60.9%
Material frayed60.9%
Microbial contamination of device60.9%
Product quality problem60.9%

Questions about accessories, cleaning brushes, for endoscope reports

What is product code MNL?

FDA's classification code for "Accessories, cleaning brushes, for endoscope", class 1, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

674 reports through August 2026, 115 of them in the latest 12 months.

Which brands appear most often?

HedgeHog (251), 6 Shooter Saeed Multi-Band Ligator (1) and Verify (1). 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.