Device brand name · Fzp
Direct Drive Disposable Clip Applier 10mm 3/Box: medical device reports filed with FDA
506 reports name it, 2010–2017. Manufacturer given most often on reports: Applied Medical. Product code FZP.
- 506
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 76.7%
- 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 506 reports that name the brand "Direct Drive Disposable Clip Applier 10mm 3/Box" (fzp), received between November 2010 and March 2017; the manufacturer given most often on reports is Applied Medical. 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 (76.7%), injury (3.6%) and other (2.4%); 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 (41.7%), device operates differently than expected (32.2%) and misfire (21.7%). The patient problems coded most often are failure of implant, perforation of vessels 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 Direct Drive Disposable Clip Applier 10mm 3/Box 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 |
|---|---|---|---|
| Failure to form staple | 211 | 41.7% | 27.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 163 | 32.2% | 4.6% |
| Misfire | 110 | 21.7% | 5.7% |
| Malfunction | 64 | 12.6% | 0.5% |
| Failure to adhere or bond | 60 | 11.9% | 1.6% |
| Mechanical jam | 59 | 11.7% | 6.4% |
| Failure to align | 36 | 7.1% | 1.1% |
| Unintended ejection | 12 | 2.4% | 1.9% |
| Device maintenance issue | 8 | 1.6% | 0.1% |
| Positioning failure | 6 | 1.2% | 3.5% |
| Activation, positioning or separation problem | 4 | 0.8% | 2.3% |
| Delivery system failure | 3 | 0.6% | 0% |
| Device issuea problem with the device | 3 | 0.6% | 0.7% |
| Detachment of device component | 2 | 0.4% | 1.6% |
| Failure to fire | 2 | 0.4% | 8% |
| Breakthe device broke | 1 | 0.2% | 4.2% |
| Chemical problem | 1 | 0.2% | 0% |
| Component falling | 1 | 0.2% | 3.8% |
| Defective devicethe device was defective | 1 | 0.2% | 0.3% |
| Device dislodged or dislocated | 1 | 0.2% | 0.8% |
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 |
|---|---|---|
| Failure of implant | 9 | 1.8% |
| Perforation of vessels | 9 | 1.8% |
| Injurya physical injury | 8 | 1.6% |
| Failure to anastomose | 7 | 1.4% |
| Bleeding | 4 | 0.8% |
| Blood loss | 4 | 0.8% |
| Extravasation | 4 | 0.8% |
| Hemostasis | 3 | 0.6% |
| Device embedded in tissue or plaque | 2 | 0.4% |
| No patient involvement | 2 | 0.4% |
| Surgical procedure, repeated | 2 | 0.4% |
| Brain injury | 1 | 0.2% |
| Complaint, ill-defined | 1 | 0.2% |
| Foreign body, removal of | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Direct Drive Disposable Clip Applier 10mm 3/Box | Product code FZP | All MAUDE reports |
|---|---|---|---|
| Reports | 506 | 42,395 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 3.6% | 8% | 36.2% |
| Classified as malfunction | 76.7% | 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% |
| 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 Direct Drive Disposable Clip Applier 10mm 3/Box reports
How many FDA reports name Direct Drive Disposable Clip Applier 10mm 3/Box?
506 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 (76.7%), injury (3.6%) and other (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to form staple (41.7%), device operates differently than expected (32.2%), misfire (21.7%), malfunction (12.6%) and failure to adhere or bond (11.9%). 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 Direct Drive Disposable Clip Applier 10mm 3/Box 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.