Reported Reactions

Devices › Applier, surgical, clip

Device brand name · Clip applier

Ligaclip Multiple Clip Applier: medical device reports filed with FDA

1,069 reports name it, 1996–2016. Manufacturer given most often on reports: Lacey Manufacturing. Product code GDO.

1,069
device reports naming the brand
0% of all MAUDE reports · about 36 a year
0
reports, 12 months to August 2026
0 in the 12 months before
97.5%
classified as malfunction
91.5% across the product code
0.2%
classified as death, as reported
2 reports · not verified by FDA

1,069 medical device reports received by FDA name the brand "Ligaclip Multiple Clip Applier" (clip applier); the manufacturer given most often on reports is Lacey Manufacturing; received from September 1996 to November 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (97.5%), injury (2.2%) and death (0.2%); across all applier, surgical, clip reports (product code GDO) death is recorded in 0.2% and malfunction in 91.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are replace (59.3%), failure to deliver (22.7%) and failure to form staple (22.4%). The patient problems coded most often are failure to anastomose, perforation of vessels and bleeding. 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

No report naming Ligaclip Multiple Clip Applier was received in the five years to August 2026; the latest was received in November 2016.

By year received

01583161996: 2619961997: 661998: 14819981999: 3162000: 26620002001: 942003: 2920032004: 262006: 320062012: 112014: 1220142015: 262016: 462016

Event type and report source

Event type, as classified on the report

Death0.2%2
Injury2.2%24
Malfunction97.5%1,042
Other0%0
Not given0.1%1

Who filed the report

Manufacturer report99.9%1,068
Voluntary report0.1%1
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 16,592 reports carrying product code GDO. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Replace63459.3%31%
Failure to deliverthe device did not deliver the dose or item24322.7%4.2%
Failure to form staple23922.4%26.8%
Misfire16615.5%9.4%
Failure to advance817.6%2.9%
Sticking817.6%6.1%
Clips, scissored706.5%7.4%
Failure to fire535%4.7%
Filling problem504.7%1.3%
Device operates differently than expectedthe device behaved unexpectedly201.9%3%
Malfunction201.9%1.4%
Failure to adhere or bond191.8%0.7%
Detachment of device component181.7%2.3%
Close, difficult to171.6%1.9%
Device issuea problem with the device141.3%3.1%
Component falling90.8%2.2%
Material separation90.8%1.3%
Other (for use when an appropriate device code cannot be identified)90.8%1.1%
Breakthe device broke70.7%5%
Component missing60.6%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
Failure to anastomose54250.7%
Perforation of vessels232.2%
Bleeding191.8%
Surgery, prolonged141.3%
Foreign body, removal of121.1%
Dural tear100.9%
Blood loss70.7%
Other (for use when an appropriate patient code cannot be identified)70.7%
Cut(s)40.4%
Surgical procedure aborted/stopped40.4%
Transfusion of blood products30.3%
Deaththe patient died; cause not stated by this term20.2%
Abdominal painstomach or belly pain10.1%
Device induced10.1%
Hemostasis10.1%

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

In context

MeasureLigaclip Multiple Clip ApplierProduct code GDOAll MAUDE reports
Reports1,06916,59226,136,888
Share of that pool—6.4%0%
Classified as death, per 1,000 reports229
Classified as injury2.2%6.5%36.2%
Classified as malfunction97.5%91.5%62.3%
Filed by the manufacturer99.9%93.3%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 GDO

BrandReportsLatest 12 monthsClassified as death
Ligaclip Endoscopic Rotating Multiple Clip Applier4,35100.1%
Weck Hol Ml 5mm Endo Applier5783060%
Ligaclip Mca Small Applier557190.2%
Ligaclip Endoscopic Multiple Clip Applier56000%
Ligaclip Endoscopic Rotating Multiple Clip Applier 2082100%
Ligaclip Mca Med Applier51340.4%
Hol Ml 5mm Endo Applier45700%
Ligaclip Rotating Multiple Clip Applier46300%
Ligaclip Endo Rotating Mca2,2091090%
Ligaclip Mca Med Long Applier40890.2%
Ligaclip Clip Applier1,78700%
Ligaclip1,4253080%
Resolution Clip Device1,59600.3%
Ligaclip Mca Large Applier26830.4%
Ligaclip 20/20 Multiple Clip Applier25000%

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 Ligaclip Multiple Clip Applier reports

How many FDA reports name Ligaclip Multiple Clip Applier?

1,069 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 (97.5%), injury (2.2%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

replace (59.3%), failure to deliver (22.7%), failure to form staple (22.4%), misfire (15.5%) and failure to advance (7.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Ligaclip Multiple Clip Applier 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.