Reported Reactions

Devices › Clip, implantable

Device brand name · Fzp

Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Medium: medical device reports filed with FDA

187 reports name it, 2006–2010. Manufacturer given most often on reports: Ethicon Endo-Surgery Cincinnati. Product code FZP.

187
device reports naming the brand
0% of all MAUDE reports · about 9 a year
0
reports, 12 months to August 2026
0 in the 12 months before
90.9%
classified as malfunction
90.6% across the product code
0.5%
classified as death, as reported
1 reports · not verified by FDA

187 medical device reports received by FDA name the brand "Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Medium" (fzp); the manufacturer given most often on reports is Ethicon Endo-Surgery Cincinnati; received from October 2006 to June 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 (90.9%), injury (8.6%) and death (0.5%); 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 (60.4%), failure to form staple (41.2%) and clips, scissored (15%). The patient problems coded most often are failure to anastomose, surgical procedure, additional and hospitalization required. 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 was received in the five years to August 2026; the latest was received in June 2010.

By year received

0571132006: 5220062007: 11320072008: 620082009: 1220092010: 42010

Event type and report source

Event type, as classified on the report

Death0.5%1
Injury8.6%16
Malfunction90.9%170
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.5%186
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.5%1

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
Replace11360.4%6.3%
Failure to form staple7741.2%27.7%
Clips, scissored2815%1%
Component falling2312.3%3.8%
Device issuea problem with the device2211.8%0.7%
Failure to fire126.4%8%
Close, difficult to63.2%0.3%
Detachment of device component63.2%1.6%
Misfire63.2%5.7%
Leak/splashthe device leaked52.7%0.5%
Failure to advance42.1%1.3%
Loose42.1%0.2%
Breakthe device broke21.1%4.2%
Fluid/blood leak21.1%0.2%
Material separation21.1%0.2%
Mechanical jam21.1%6.4%
Positioning failure21.1%3.5%
Sticking21.1%2.7%
Bent10.5%0.3%
Device inoperablethe device could not be used10.5%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 anastomose4524.1%
Surgical procedure, additional126.4%
Hospitalization required73.7%
Bleeding52.7%
Foreign body, removal of52.7%
Therapy/non-surgical treatment, additional42.1%
Other (for use when an appropriate patient code cannot be identified)31.6%
Abdominal painstomach or belly pain21.1%
Allergic reactionan allergic reaction21.1%
Rashskin rash21.1%
Blood loss10.5%
Deaththe patient died; cause not stated by this term10.5%
Dural tear10.5%
Hives10.5%
Itching sensation10.5%

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

In context

MeasureLigaclip Endoscopic Rotating Multiple Clip Applier 20 MediumProduct code FZPAll MAUDE reports
Reports18742,39526,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports539
Classified as injury8.6%8%36.2%
Classified as malfunction90.9%90.6%62.3%
Filed by the manufacturer99.5%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 reports

How many FDA reports name Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Medium?

187 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 (90.9%), injury (8.6%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

replace (60.4%), failure to form staple (41.2%), clips, scissored (15%), component falling (12.3%) and device issue (11.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.5%). 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 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.