Reported Reactions

Devices › Clip, implantable

Device brand name · Clip implantable

Lapra-Ty Absorbable X6 Suture Clip: medical device reports filed with FDA

828 reports name it, 2017–2026. Manufacturer given most often on reports: Ethicon. Product code FZP.

828
device reports naming the brand
0% of all MAUDE reports · about 94 a year
118
reports, 12 months to August 2026
248 in the 12 months before
99.8%
classified as malfunction
90.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

828 medical device reports received by FDA name the brand "Lapra-Ty Absorbable X6 Suture Clip" (clip implantable); the manufacturer given most often on reports is Ethicon; received from September 2017 to April 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

118 reports arrived in the 12 months to August 2026, down 52% from 248 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 (99.8%) and injury (0.2%); 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 positioning failure (92.4%), failure to adhere or bond (2.3%) and break (1.3%). The patient problems coded most often are blood loss, not applicable and fever. 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

03060Sep 2021: 1Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 2Mar 2022: 4Apr 2022: 14May 2022: 8Jun 2022: 6Jul 2022: 18Aug 2022: 4Sep 2022: 12Oct 2022: 18Nov 2022: 9Dec 2022: 192023Jan 2023: 6Feb 2023: 7Mar 2023: 1Apr 2023: 11May 2023: 14Jun 2023: 20Jul 2023: 9Aug 2023: 15Sep 2023: 41Oct 2023: 53Nov 2023: 26Dec 2023: 92024Jan 2024: 7Feb 2024: 20Mar 2024: 6Apr 2024: 12May 2024: 6Jun 2024: 18Jul 2024: 3Aug 2024: 2Sep 2024: 24Oct 2024: 11Nov 2024: 28Dec 2024: 602025Jan 2025: 12Feb 2025: 9Mar 2025: 7Apr 2025: 23May 2025: 15Jun 2025: 23Jul 2025: 15Aug 2025: 21Sep 2025: 22Oct 2025: 18Nov 2025: 28Dec 2025: 242026Jan 2026: 0Feb 2026: 19Mar 2026: 2Apr 2026: 5May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

01092172017: 320172018: 2220182019: 520192020: 1820202021: 1420212022: 11420222023: 21220232024: 19720242025: 21720252026: 262026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.2%2
Malfunction99.8%826
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%828
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
Positioning failure76592.4%3.5%
Failure to adhere or bond192.3%1.6%
Breakthe device broke111.3%4.2%
Material integrity problema problem with the device material91.1%0.3%
Tear, rip or hole in device packaging70.8%0.3%
Delivered as unsterile product60.7%0.2%
Difficult to open or close50.6%8.1%
Positioning problem30.4%0.2%
Device contaminated during manufacture or shipping10.1%0%
Insufficient device problem information10.1%1.4%
Mechanical problema mechanical problem10.1%5.9%
Packaging problem10.1%0%
Product quality problem10.1%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
Blood loss20.2%
Not applicable20.2%
Fever10.1%

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

In context

MeasureLapra-Ty Absorbable X6 Suture ClipProduct code FZPAll MAUDE reports
Reports82842,39526,136,888
Share of that pool—2%0%
Classified as death, per 1,000 reports039
Classified as injury0.2%8%36.2%
Classified as malfunction99.8%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%
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 Lapra-Ty Absorbable X6 Suture Clip reports

How many FDA reports name Lapra-Ty Absorbable X6 Suture Clip?

828 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 118 in the latest 12 months.

What kinds of events are reported?

malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

positioning failure (92.4%), failure to adhere or bond (2.3%), break (1.3%), material integrity problem (1.1%) and tear, rip or hole in device packaging (0.8%). 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 Lapra-Ty Absorbable X6 Suture Clip 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.