Device brand name · Fzp
Ca090 Direct Drive Lca 3/Bx: medical device reports filed with FDA
1,143 reports name it, 2014–2017. Manufacturer given most often on reports: Applied Medical Resources. Product code FZP.
- 1,143
- device reports naming the brand
- 0% of all MAUDE reports · about 97 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 92.7%
- classified as malfunction
- 90.6% across the product code
- 0.2%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 1,143 reports that name the brand "Ca090 Direct Drive Lca 3/Bx" (fzp), received between September 2014 and March 2017; the manufacturer given most often on reports is Applied Medical Resources. 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 (92.7%), injury (6.9%) and death (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 misfire (34.2%), failure to form staple (30.5%) and failure to adhere or bond (28.5%). The patient problems coded most often are extravasation, blood loss and injury. 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 Ca090 Direct Drive Lca 3/Bx was received in the five years to August 2026; the latest was received in March 2017.
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 |
|---|---|---|---|
| Misfire | 391 | 34.2% | 5.7% |
| Failure to form staple | 349 | 30.5% | 27.7% |
| Failure to adhere or bond | 326 | 28.5% | 1.6% |
| Mechanical jam | 132 | 11.5% | 6.4% |
| Unintended ejection | 98 | 8.6% | 1.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 39 | 3.4% | 4.6% |
| Material deformation | 20 | 1.7% | 2.1% |
| Mechanics altered | 17 | 1.5% | 9.4% |
| Difficult to open or close | 12 | 1% | 8.1% |
| Physical resistance | 9 | 0.8% | 0.2% |
| Activation, positioning or separation problem | 8 | 0.7% | 2.3% |
| Expulsion | 6 | 0.5% | 0% |
| Failure to fire | 6 | 0.5% | 8% |
| Component falling | 5 | 0.4% | 3.8% |
| Failure to align | 5 | 0.4% | 1.1% |
| Loose or intermittent connection | 4 | 0.3% | 0.3% |
| Material integrity problema problem with the device material | 3 | 0.3% | 0.3% |
| Bent | 2 | 0.2% | 0.3% |
| Chemical problem | 2 | 0.2% | 0% |
| Device slipped | 2 | 0.2% | 1.8% |
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 |
|---|---|---|
| Extravasation | 26 | 2.3% |
| Blood loss | 10 | 0.9% |
| Injurya physical injury | 7 | 0.6% |
| Hemorrhage/blood loss/bleeding | 6 | 0.5% |
| Tissue damage | 6 | 0.5% |
| Failure to anastomose | 4 | 0.3% |
| Perforation | 4 | 0.3% |
| Abdominal painstomach or belly pain | 2 | 0.2% |
| Deaththe patient died; cause not stated by this term | 2 | 0.2% |
| Fever | 2 | 0.2% |
| Internal organ perforation | 2 | 0.2% |
| Abscessa collection of pus | 1 | 0.1% |
| Bowel perforation | 1 | 0.1% |
| Fluid discharge | 1 | 0.1% |
| Hemostasis | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ca090 Direct Drive Lca 3/Bx | Product code FZP | All MAUDE reports |
|---|---|---|---|
| Reports | 1,143 | 42,395 | 26,136,888 |
| Share of that pool | — | 2.7% | 0% |
| Classified as death, per 1,000 reports | 2 | 3 | 9 |
| Classified as injury | 6.9% | 8% | 36.2% |
| Classified as malfunction | 92.7% | 90.6% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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 Ca090 Direct Drive Lca 3/Bx reports
How many FDA reports name Ca090 Direct Drive Lca 3/Bx?
1,143 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 (92.7%), injury (6.9%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
misfire (34.2%), failure to form staple (30.5%), failure to adhere or bond (28.5%), mechanical jam (11.5%) and unintended ejection (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 Ca090 Direct Drive Lca 3/Bx 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.