Device brand name · Clip implantable
Ligamax 5mm: medical device reports filed with FDA
465 reports name it, 2010–2016. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code FZP.
- 465
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 95.9%
- 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 465 reports that name the brand "Ligamax 5mm" (clip implantable), received between March 2010 and September 2016; the manufacturer given most often on reports is Ethicon Endo-Surgery. Spellings of one product vary from report to report.
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 (95.9%) and injury (4.1%); 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 failure to form staple (37%), failure to fire (12.7%) and device operates differently than expected (10.1%). The patient problems coded most often are bleeding, other (for use when an appropriate patient code cannot be identified) and surgical procedure. 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 Ligamax 5mm was received in the five years to August 2026; the latest was received in September 2016.
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 |
|---|---|---|---|
| Failure to form staple | 172 | 37% | 27.7% |
| Failure to fire | 59 | 12.7% | 8% |
| Device operates differently than expectedthe device behaved unexpectedly | 47 | 10.1% | 4.6% |
| Difficult to open or close | 43 | 9.2% | 8.1% |
| Mechanical jam | 42 | 9% | 6.4% |
| Misfire | 35 | 7.5% | 5.7% |
| Component falling | 22 | 4.7% | 3.8% |
| Mechanical problema mechanical problem | 13 | 2.8% | 5.9% |
| Positioning failure | 12 | 2.6% | 3.5% |
| Material deformation | 11 | 2.4% | 2.1% |
| Failure to advance | 10 | 2.2% | 1.3% |
| Sticking | 9 | 1.9% | 2.7% |
| Breakthe device broke | 8 | 1.7% | 4.2% |
| Device inoperablethe device could not be used | 8 | 1.7% | 0.6% |
| Activation, positioning or separation problem | 7 | 1.5% | 2.3% |
| Leak/splashthe device leaked | 6 | 1.3% | 0.5% |
| Difficult to removethe device was hard to remove | 5 | 1.1% | 1.3% |
| Bent | 4 | 0.9% | 0.3% |
| Failure to adhere or bond | 4 | 0.9% | 1.6% |
| Component missing | 3 | 0.6% | 0.2% |
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 |
|---|---|---|
| Bleeding | 8 | 1.7% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 1.1% |
| Surgical procedure | 4 | 0.9% |
| Tissue damage | 4 | 0.9% |
| No patient involvement | 3 | 0.6% |
| Surgical procedure, additional | 3 | 0.6% |
| Abdominal distention | 2 | 0.4% |
| Blood loss | 2 | 0.4% |
| Dural tear | 2 | 0.4% |
| Hospitalization required | 2 | 0.4% |
| Abdominal painstomach or belly pain | 1 | 0.2% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.2% |
| Leak(s), perivalvular | 1 | 0.2% |
| Surgery, prolonged | 1 | 0.2% |
| Surgical procedure, repeated | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ligamax 5mm | Product code FZP | All MAUDE reports |
|---|---|---|---|
| Reports | 465 | 42,395 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 4.1% | 8% | 36.2% |
| Classified as malfunction | 95.9% | 90.6% | 62.3% |
| Filed by the manufacturer | 99.4% | 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% |
| Endo Clip | 1,308 | 85 | 0.1% |
| 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% |
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 Ligamax 5mm reports
How many FDA reports name Ligamax 5mm?
465 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 (95.9%) and injury (4.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to form staple (37%), failure to fire (12.7%), device operates differently than expected (10.1%), difficult to open or close (9.2%) and mechanical jam (9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ligamax 5mm 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.