Reported Reactions

Devices › Ligator, esophageal

Device brand name · Mnd ligator esophageal

6 Shooter Saeed Multi-Band Ligator: medical device reports filed with FDA

1,440 reports name it, 2008–2026. Manufacturer given most often on reports: Wilson-Cook Medical. Product code MND.

1,440
device reports naming the brand
0% of all MAUDE reports · about 80 a year
92
reports, 12 months to August 2026
108 in the 12 months before
89.4%
classified as malfunction
90.4% across the product code
0.1%
classified as death, as reported
2 reports · not verified by FDA

1,440 medical device reports received by FDA name the brand "6 Shooter Saeed Multi-Band Ligator" (mnd ligator esophageal); the manufacturer given most often on reports is Wilson-Cook Medical; received from August 2008 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

92 reports arrived in the 12 months to August 2026, down 15% from 108 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 (89.4%), injury (10.4%) and death (0.1%); across all ligator, esophageal reports (product code MND) death is recorded in 0.7% and malfunction in 90.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are premature activation (22.8%), failure to fire (19%) and detachment of device component (11.9%). The patient problems coded most often are foreign body in patient, no patient involvement and gastrointestinal hemorrhage. 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

01020Sep 2021: 2Oct 2021: 7Nov 2021: 10Dec 2021: 202022Jan 2022: 3Feb 2022: 6Mar 2022: 6Apr 2022: 6May 2022: 7Jun 2022: 10Jul 2022: 11Aug 2022: 14Sep 2022: 9Oct 2022: 11Nov 2022: 4Dec 2022: 42023Jan 2023: 7Feb 2023: 8Mar 2023: 12Apr 2023: 9May 2023: 10Jun 2023: 7Jul 2023: 7Aug 2023: 7Sep 2023: 6Oct 2023: 6Nov 2023: 10Dec 2023: 102024Jan 2024: 12Feb 2024: 15Mar 2024: 10Apr 2024: 8May 2024: 9Jun 2024: 12Jul 2024: 9Aug 2024: 4Sep 2024: 8Oct 2024: 10Nov 2024: 15Dec 2024: 72025Jan 2025: 13Feb 2025: 8Mar 2025: 11Apr 2025: 9May 2025: 2Jun 2025: 4Jul 2025: 8Aug 2025: 13Sep 2025: 8Oct 2025: 5Nov 2025: 10Dec 2025: 42026Jan 2026: 9Feb 2026: 7Mar 2026: 6Apr 2026: 9May 2026: 6Jun 2026: 8Jul 2026: 5Aug 2026: 15

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

0701402008: 1620082009: 162010: 5820102011: 1402012: 12320122013: 702014: 4120142015: 512016: 7320162017: 722018: 7020182019: 802020: 6920202021: 922022: 9120222023: 992024: 11920242025: 952026: 652026

Event type and report source

Event type, as classified on the report

Death0.1%2
Injury10.4%150
Malfunction89.4%1,287
Other0%0
Not given0.1%1

Who filed the report

Manufacturer report99.9%1,439
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.1%1

Grey bar: all 10,742 reports carrying product code MND. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Premature activation32922.8%10.7%
Failure to fire27319%33.1%
Detachment of device component17111.9%4.2%
Device dislodged or dislocated1248.6%1.5%
Positioning failure1168.1%9.4%
Material separation1127.8%3.1%
Breakthe device broke956.6%7.3%
Detachment of device or device componentpart of the device came off584%2%
Material too soft/flexible543.8%0.5%
Difficult or delayed positioning533.7%2.4%
Device operates differently than expectedthe device behaved unexpectedly463.2%0.7%
Premature separation382.6%0.4%
Migration or expulsion of device352.4%0.7%
Improper or incorrect procedure or method332.3%0.3%
Unintended movement271.9%0.3%
Device-device incompatibility221.5%0.2%
Component falling211.5%0.6%
Device handling problem201.4%0.2%
Fracturea broken bone191.3%0.8%
Compatibility problem141%0.1%

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
Foreign body in patientpart of a device left in the patient20013.9%
No patient involvement825.7%
Gastrointestinal hemorrhage312.2%
Hemorrhage/blood loss/bleeding312.2%
Hemostasis141%
Device embedded in tissue or plaque100.7%
Laceration(s) of esophagus40.3%
Vomitingbeing sick40.3%
Foreign body, removal of30.2%
Airway obstruction20.1%
Chest painchest pain20.1%
Discomfortdiscomfort20.1%
Hypersensitivity/allergic reaction20.1%
Laceration(s)20.1%
Respiratory distressdifficulty breathing20.1%

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

In context

Measure6 Shooter Saeed Multi-Band LigatorProduct code MNDAll MAUDE reports
Reports1,44010,74226,136,888
Share of that pool—13.4%0%
Classified as death, per 1,000 reports179
Classified as injury10.4%8.7%36.2%
Classified as malfunction89.4%90.4%62.3%
Filed by the manufacturer99.9%98.2%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 MND

BrandReportsLatest 12 monthsClassified as death
Speedband Superview Super 76,0886400.2%
Resolution Clip Device1,59600.3%
Resolution Clip Clipping Device2,382280.1%
Resolution Hemostasis Clipping Device67401.5%
Single Use Ligating Device5941700%
Instinct Endoscopic Hemoclip78400.1%
Resolution Clip884360.1%
Olympus2,24092.5%
Instinct1,2151,1710%
Cook27162.2%
Gold Probe236150%

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 6 Shooter Saeed Multi-Band Ligator reports

How many FDA reports name 6 Shooter Saeed Multi-Band Ligator?

1,440 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 92 in the latest 12 months.

What kinds of events are reported?

malfunction (89.4%), injury (10.4%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

premature activation (22.8%), failure to fire (19%), detachment of device component (11.9%), device dislodged or dislocated (8.6%) and positioning failure (8.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that 6 Shooter Saeed Multi-Band Ligator 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.