Device brand name · Fzp clip implantable
8g Mammomark Breast Marker: medical device reports filed with FDA
177 reports name it, 2005–2010. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code FZP.
- 177
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 88.1%
- classified as malfunction
- 90.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
177 medical device reports received by FDA name the brand "8g Mammomark Breast Marker" (fzp clip implantable); the manufacturer given most often on reports is Ethicon Endo-Surgery; received from June 2005 to August 2010. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (88.1%) and injury (11.3%); 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 positioning failure (40.7%), replace (24.3%) and break (19.2%). The patient problems coded most often are nonresorbable materials, unretrieved in body, other (for use when an appropriate patient code cannot be identified) and foreign body, removal of. 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 8g Mammomark Breast Marker was received in the five years to August 2026; the latest was received in August 2010.
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 |
|---|---|---|---|
| Positioning failure | 72 | 40.7% | 3.5% |
| Replace | 43 | 24.3% | 6.3% |
| Breakthe device broke | 34 | 19.2% | 4.2% |
| Tip breakage | 26 | 14.7% | 0.3% |
| Device, or device fragments remain in patient | 16 | 9% | 0.2% |
| Detachment of device component | 13 | 7.3% | 1.6% |
| Device, removal of (non-implant) | 9 | 5.1% | 0.4% |
| Material separation | 8 | 4.5% | 0.2% |
| Difficult or delayed positioning | 6 | 3.4% | 0.2% |
| Component(s), broken | 5 | 2.8% | 0.2% |
| Device or device fragments location unknown | 5 | 2.8% | 0.1% |
| Insufficient device problem information | 5 | 2.8% | 1.4% |
| Component falling | 4 | 2.3% | 3.8% |
| Sticking | 4 | 2.3% | 2.7% |
| Difficult to removethe device was hard to remove | 3 | 1.7% | 1.3% |
| Failure to form staple | 3 | 1.7% | 27.7% |
| Mechanical jam | 3 | 1.7% | 6.4% |
| Failure to fire | 2 | 1.1% | 8% |
| Sharp/jagged/rough/etched/scratched | 2 | 1.1% | 0% |
| Activation, positioning or separation problem | 1 | 0.6% | 2.3% |
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 |
|---|---|---|
| Nonresorbable materials, unretrieved in body | 19 | 10.7% |
| Other (for use when an appropriate patient code cannot be identified) | 13 | 7.3% |
| Foreign body, removal of | 8 | 4.5% |
| Painpain, site not specified | 4 | 2.3% |
| Allergic reactionan allergic reaction | 1 | 0.6% |
| Bleeding | 1 | 0.6% |
| Device embedded in tissue or plaque | 1 | 0.6% |
| Failure to anastomose | 1 | 0.6% |
| No patient involvement | 1 | 0.6% |
| Surgical procedure aborted/stopped | 1 | 0.6% |
| Surgical procedure, additional | 1 | 0.6% |
| Therapy/non-surgical treatment, additional | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 8g Mammomark Breast Marker | Product code FZP | All MAUDE reports |
|---|---|---|---|
| Reports | 177 | 42,395 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 11.3% | 8% | 36.2% |
| Classified as malfunction | 88.1% | 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 8g Mammomark Breast Marker reports
How many FDA reports name 8g Mammomark Breast Marker?
177 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 (88.1%) and injury (11.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
positioning failure (40.7%), replace (24.3%), break (19.2%), tip breakage (14.7%) and device, or device fragments remain in patient (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 8g Mammomark Breast Marker 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.