Device brand name · Clip implantable
Endo Clip: medical device reports filed with FDA
1,308 reports name it, 2004–2026. Manufacturer given most often on reports: Davis & Geck Caribe. Product code FZP.
- 1,308
- device reports naming the brand
- 0% of all MAUDE reports · about 58 a year
- 85
- reports, 12 months to August 2026
- 99 in the 12 months before
- 93.6%
- classified as malfunction
- 90.6% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,308 medical device reports received by FDA name the brand "Endo Clip" (clip implantable); the manufacturer given most often on reports is Davis & Geck Caribe; received from February 2004 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
85 reports arrived in the 12 months to August 2026, down 14% from 99 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 (93.6%), injury (6.3%) and death (0.1%); 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 mechanics altered (53.1%), mechanical problem (25.1%) and material deformation (9.6%). The patient problems coded most often are no patient involvement, tissue breakdown and hemorrhage/blood loss/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
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
Event type and report source
Event type, as classified on the report
Who filed the report
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) | Reports | Share | Share across product code |
|---|---|---|---|
| Mechanics altered | 695 | 53.1% | 9.4% |
| Mechanical problema mechanical problem | 328 | 25.1% | 5.9% |
| Material deformation | 125 | 9.6% | 2.1% |
| Difficult to open or close | 99 | 7.6% | 8.1% |
| Detachment of device or device componentpart of the device came off | 96 | 7.3% | 1.7% |
| Breakthe device broke | 59 | 4.5% | 4.2% |
| Device slipped | 55 | 4.2% | 1.8% |
| Fail-safe problem | 44 | 3.4% | 0.4% |
| Failure to fire | 30 | 2.3% | 8% |
| Detachment of device component | 17 | 1.3% | 1.6% |
| Failure to align | 17 | 1.3% | 1.1% |
| Mechanical jam | 14 | 1.1% | 6.4% |
| Display or visual feedback problem | 12 | 0.9% | 0.3% |
| Noise, audible | 12 | 0.9% | 0.3% |
| Firing problem | 11 | 0.8% | 0.8% |
| Component missing | 10 | 0.8% | 0.2% |
| Failure to form staple | 10 | 0.8% | 27.7% |
| Entrapment of device | 6 | 0.5% | 0.7% |
| Physical resistance | 4 | 0.3% | 0.2% |
| Defective devicethe device was defective | 3 | 0.2% | 0.3% |
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) | Reports | Share |
|---|---|---|
| No patient involvement | 31 | 2.4% |
| Tissue breakdown | 23 | 1.8% |
| Hemorrhage/blood loss/bleeding | 17 | 1.3% |
| Biliary leak | 15 | 1.1% |
| Tissue damage | 14 | 1.1% |
| Blood loss | 7 | 0.5% |
| Foreign body in patientpart of a device left in the patient | 7 | 0.5% |
| Unintended radiation exposure | 7 | 0.5% |
| Injurya physical injury | 6 | 0.5% |
| Radiation exposure, unintended | 3 | 0.2% |
| Device embedded in tissue or plaque | 2 | 0.2% |
| Anemialow red blood cells | 1 | 0.1% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
| Exsanguination | 1 | 0.1% |
| Needle stick/puncture | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endo Clip | Product code FZP | All MAUDE reports |
|---|---|---|---|
| Reports | 1,308 | 42,395 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 1 | 3 | 9 |
| Classified as injury | 6.3% | 8% | 36.2% |
| Classified as malfunction | 93.6% | 90.6% | 62.3% |
| Filed by the manufacturer | 95.6% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ligamax-5mm Endo Clip Applier | 6,836 | 234 | 0% |
| Auto Endo5 Ml | 2,069 | 22 | 0% |
| Rotating Multiple Clip Applier | 1,798 | 0 | 0.2% |
| Ligaclip Endo Rotating Mca | 2,209 | 109 | 0% |
| Ligaclip Clip Applier | 1,787 | 0 | 0% |
| Ligaclip Endoscopic Clip Applier | 1,278 | 0 | 0% |
| Ligamax-5mm | 1,222 | 0 | 0.1% |
| Ca500 Epix Universal Clip Applier 3/Bx | 1,154 | 0 | 0.1% |
| Ca090 Direct Drive Lca 3/Bx | 1,143 | 0 | 0.2% |
| Ligaclip | 1,425 | 308 | 0% |
| Ligamax | 1,029 | 308 | 0% |
| Epix Universal Clip Applier | 866 | 232 | 0% |
| Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large Titanium Ligating Cl | 859 | 0 | 0% |
| Lapra-Ty Absorbable X6 Suture Clip | 828 | 118 | 0% |
| Ligamax Clip Applier | 736 | 0 | 0.1% |
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 Endo Clip reports
How many FDA reports name Endo Clip?
1,308 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 85 in the latest 12 months.
What kinds of events are reported?
malfunction (93.6%), injury (6.3%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanics altered (53.1%), mechanical problem (25.1%), material deformation (9.6%), difficult to open or close (7.6%) and detachment of device or device component (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.6%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Endo 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.