Reported Reactions

Devices › Clip, implantable

Device brand name · Fzp

Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large Titanium Ligating Cl: medical device reports filed with FDA

859 reports name it, 2007–2009. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code FZP.

859
device reports naming the brand
0% of all MAUDE reports · about 44 a year
0
reports, 12 months to August 2026
0 in the 12 months before
99.1%
classified as malfunction
90.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

859 medical device reports received by FDA name the brand "Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large Titanium Ligating Cl" (fzp); the manufacturer given most often on reports is Ethicon Endo-Surgery; received from March 2007 to December 2009. 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 (99.1%) and injury (0.7%); 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 replace (48.7%), failure to form staple (36.4%) and misfire (17.2%). The patient problems coded most often are failure to anastomose, foreign body, removal of and no patient involvement. 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 Large Titanium Ligating Cl was received in the five years to August 2026; the latest was received in December 2009.

By year received

01753492007: 34920072008: 21220082009: 2982009

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.7%6
Malfunction99.1%851
Other0%0
Not given0.2%2

Who filed the report

Manufacturer report100%859
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
Replace41848.7%6.3%
Failure to form staple31336.4%27.7%
Misfire14817.2%5.7%
Component falling12514.6%3.8%
Unintended ejection809.3%1.9%
Clips, scissored566.5%1%
Sticking556.4%2.7%
Detachment of device component465.4%1.6%
Failure to advance384.4%1.3%
Device, removal of (non-implant)222.6%0.4%
Device issuea problem with the device202.3%0.7%
Mechanical jam202.3%6.4%
Failure to fire192.2%8%
Close, difficult to161.9%0.3%
Difficult to open or close141.6%8.1%
Device operates differently than expectedthe device behaved unexpectedly131.5%4.6%
Loose121.4%0.2%
Positioning failure121.4%3.5%
Failure to align111.3%1.1%
Device dislodged or dislocated80.9%0.8%

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 anastomose12915%
Foreign body, removal of303.5%
No patient involvement60.7%
Dural tear30.3%
Laparotomy30.3%
Nonresorbable materials, unretrieved in body20.2%
Perforation of vessels20.2%
Surgical procedure, additional20.2%
Therapy/non-surgical treatment, additional20.2%
Bleeding10.1%
Hemorrhage, extradural10.1%
Laceration(s)10.1%
Leak(s), perivalvular10.1%
Perforation10.1%
Surgery, prolonged10.1%

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

In context

MeasureLigaclip Endoscopic Rotating Multiple Clip Applier 20 Large Titanium Ligating ClProduct code FZPAll MAUDE reports
Reports85942,39526,136,888
Share of that pool—2%0%
Classified as death, per 1,000 reports039
Classified as injury0.7%8%36.2%
Classified as malfunction99.1%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%
Lapra-Ty Absorbable X6 Suture Clip8281180%
Ligamax Clip Applier73600.1%

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 Large Titanium Ligating Cl reports

How many FDA reports name Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large Titanium Ligating Cl?

859 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 (99.1%) and injury (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

replace (48.7%), failure to form staple (36.4%), misfire (17.2%), component falling (14.6%) and unintended ejection (9.3%). 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 Large Titanium Ligating Cl 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.