Reported Reactions

Devices › Clip, implantable

Device brand name · Clip implantable

Weck Auto Endo5 Ml: medical device reports filed with FDA

209 reports name it, 2011–2026. Manufacturer given most often on reports: Teleflex Medical. Product code FZP.

209
device reports naming the brand
0% of all MAUDE reports · about 14 a year
75
reports, 12 months to August 2026
38 in the 12 months before
100%
classified as malfunction
90.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 209 reports that name the brand "Weck Auto Endo5 Ml" (clip implantable), received between October 2011 and May 2026; the manufacturer given most often on reports is Teleflex Medical. Spellings of one product vary from report to report.

75 reports arrived in the 12 months to August 2026, up 97% from 38 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 (100%); 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 firing problem (18.2%), mechanical jam (18.2%) and activation, positioning or separation problem (12.4%). 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

01427Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 9Nov 2024: 1Dec 2024: 12025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 13Jul 2025: 14Aug 2025: 0Sep 2025: 0Oct 2025: 4Nov 2025: 2Dec 2025: 92026Jan 2026: 16Feb 2026: 9Mar 2026: 27Apr 2026: 7May 2026: 1Jun 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

030602011: 320112012: 3620122013: 520132014: 2320142015: 2920152024: 1120242025: 4220252026: 602026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%209
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%209
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
Firing problem3818.2%0.8%
Mechanical jam3818.2%6.4%
Activation, positioning or separation problem2612.4%2.3%
Difficult to open or close209.6%8.1%
Failure to fire188.6%8%
Sticking178.1%2.7%
Breakthe device broke83.8%4.2%
Positioning failure83.8%3.5%
Failure to form staple41.9%27.7%
Unintended ejection41.9%1.9%
Device operates differently than expectedthe device behaved unexpectedly31.4%4.6%
Mechanics altered31.4%9.4%
Device dislodged or dislocated21%0.8%
Difficult or delayed activation21%0.1%
Material twisted/bent21%0.3%
Physical resistance/sticking21%0.2%
Component falling10.5%3.8%
Defective component10.5%0.1%
Detachment of device or device componentpart of the device came off10.5%1.7%
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.

In context

MeasureWeck Auto Endo5 MlProduct code FZPAll MAUDE reports
Reports20942,39526,136,888
Share of that pool—0.5%0%
Classified as death, per 1,000 reports039
Classified as injury0%8%36.2%
Classified as malfunction100%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 Weck Auto Endo5 Ml reports

How many FDA reports name Weck Auto Endo5 Ml?

209 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 75 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

firing problem (18.2%), mechanical jam (18.2%), activation, positioning or separation problem (12.4%), difficult to open or close (9.6%) and failure to fire (8.6%). 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 Weck Auto Endo5 Ml 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.