Reported Reactions

Devices › Clip, implantable

Device brand name · Fzp clip implantable

Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Medium-Large Titanium Liga: medical device reports filed with FDA

606 reports name it, 2007–2010. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code FZP.

606
device reports naming the brand
0% of all MAUDE reports · about 32 a year
0
reports, 12 months to August 2026
0 in the 12 months before
95.2%
classified as malfunction
90.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

606 medical device reports received by FDA name the brand "Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Medium-Large Titanium Liga" (fzp clip implantable); the manufacturer given most often on reports is Ethicon Endo-Surgery; received from May 2007 to May 2010. 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 (95.2%) and injury (4.8%); across all clip, implantable reports (product code FZP) death is recorded in 0.3% and malfunction in 90.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to form staple (49.5%), replace (34.3%) and component falling (10.9%). The patient problems coded most often are failure to anastomose, surgical procedure, additional 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 Endoscopic Rotating Multiple Clip Applier 20 Medium-Large Titanium Liga was received in the five years to August 2026; the latest was received in May 2010.

By year received

01513022007: 17420072008: 12720082009: 30220092010: 32010

Event type and report source

Event type, as classified on the report

Death0%0
Injury4.8%29
Malfunction95.2%577
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%606
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 42,395 reports carrying product code FZP. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to form staple30049.5%27.7%
Replace20834.3%6.3%
Component falling6610.9%3.8%
Misfire579.4%5.7%
Unintended ejection386.3%1.9%
Clips, scissored355.8%1%
Sticking294.8%2.7%
Detachment of device component233.8%1.6%
Failure to advance223.6%1.3%
Difficult to open or close183%8.1%
Device slipped172.8%1.8%
Loose172.8%0.2%
Mechanical jam172.8%6.4%
Failure to fire162.6%8%
Device dislodged or dislocated132.1%0.8%
Close, difficult to122%0.3%
Device operates differently than expectedthe device behaved unexpectedly101.7%4.6%
Device issuea problem with the device91.5%0.7%
Failure to align91.5%1.1%
Device, removal of (non-implant)71.2%0.4%

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 anastomose7312%
Surgical procedure, additional142.3%
Bleeding132.1%
Foreign body, removal of132.1%
Laparotomy61%
Surgery, prolonged61%
Hospitalization required40.7%
Surgical procedure40.7%
Other (for use when an appropriate patient code cannot be identified)30.5%
Nonresorbable materials, unretrieved in body20.3%
Allergic reactionan allergic reaction10.2%
Ecchymosis10.2%
Hemorrhage/blood loss/bleeding10.2%
Laceration(s)10.2%
Leak(s), perivalvular10.2%

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

In context

MeasureLigaclip Endoscopic Rotating Multiple Clip Applier 20 Medium-Large Titanium LigaProduct code FZPAll MAUDE reports
Reports60642,39526,136,888
Share of that pool—1.4%0%
Classified as death, per 1,000 reports039
Classified as injury4.8%8%36.2%
Classified as malfunction95.2%90.6%62.3%
Filed by the manufacturer100%96.6%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 FZP

BrandReportsLatest 12 monthsClassified as death
Ligamax-5mm Endo Clip Applier6,8362340%
Auto Endo5 Ml2,069220%
Rotating Multiple Clip Applier1,79800.2%
Ligaclip Endo Rotating Mca2,2091090%
Ligaclip Clip Applier1,78700%
Endo Clip1,308850.1%
Ligaclip Endoscopic Clip Applier1,27800%
Ligamax-5mm1,22200.1%
Ca500 Epix Universal Clip Applier 3/Bx1,15400.1%
Ca090 Direct Drive Lca 3/Bx1,14300.2%
Ligaclip1,4253080%
Ligamax1,0293080%
Epix Universal Clip Applier8662320%
Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large Titanium Ligating Cl85900%
Lapra-Ty Absorbable X6 Suture Clip8281180%

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 Endoscopic Rotating Multiple Clip Applier 20 Medium-Large Titanium Liga reports

How many FDA reports name Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Medium-Large Titanium Liga?

606 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 (95.2%) and injury (4.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to form staple (49.5%), replace (34.3%), component falling (10.9%), misfire (9.4%) and unintended ejection (6.3%). 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 Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Medium-Large Titanium Liga 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.