Device brand name · Fcg kit needle biopsy
Echotip Procore High Definition Ultrasound Biopsy Needle: medical device reports filed with FDA
551 reports name it, 2012–2026. Manufacturer given most often on reports: Cook Ireland. Product code FCG.
- 551
- device reports naming the brand
- 0% of all MAUDE reports · about 38 a year
- 27
- reports, 12 months to August 2026
- 29 in the 12 months before
- 78%
- classified as malfunction
- 78.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
551 medical device reports received by FDA name the brand "Echotip Procore High Definition Ultrasound Biopsy Needle" (fcg kit needle biopsy); the manufacturer given most often on reports is Cook Ireland; received from February 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
27 reports arrived in the 12 months to August 2026, close to the 29 of 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 (78%) and injury (21.8%); across all biopsy needle reports (product code FCG) death is recorded in 0.5% and malfunction in 78.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (26.7%), fracture (24.3%) and retraction problem (18.3%). The patient problems coded most often are foreign body in patient, hemorrhage/blood loss/bleeding and gastrointestinal hemorrhage. 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 4,933 reports carrying product code FCG. 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 |
|---|---|---|---|
| Breakthe device broke | 147 | 26.7% | 26.5% |
| Fracturea broken bone | 134 | 24.3% | 8.5% |
| Retraction problem | 101 | 18.3% | 6.7% |
| Improper or incorrect procedure or method | 65 | 11.8% | 4.6% |
| Material twisted/bent | 61 | 11.1% | 7.9% |
| Physical resistance/sticking | 41 | 7.4% | 2.4% |
| Kinkedthe tube or line kinked | 30 | 5.4% | 1.6% |
| Bent | 29 | 5.3% | 3.4% |
| Off-label use | 16 | 2.9% | 3.3% |
| Device-device incompatibility | 13 | 2.4% | 0.5% |
| Material deformation | 13 | 2.4% | 1.1% |
| Material perforation | 10 | 1.8% | 1.6% |
| Detachment of device component | 6 | 1.1% | 2.1% |
| Difficult to advance | 6 | 1.1% | 1.3% |
| Difficult to removethe device was hard to remove | 5 | 0.9% | 3% |
| Insufficient device problem information | 4 | 0.7% | 0.7% |
| Detachment of device or device componentpart of the device came off | 3 | 0.5% | 4% |
| Device damaged prior to usethe device was damaged before use | 3 | 0.5% | 0.5% |
| Loss of or failure to bond | 3 | 0.5% | 0.2% |
| Structural problem | 3 | 0.5% | 0.4% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 72 | 13.1% |
| Hemorrhage/blood loss/bleeding | 11 | 2% |
| Gastrointestinal hemorrhage | 8 | 1.5% |
| Painpain, site not specified | 6 | 1.1% |
| Abdominal painstomach or belly pain | 5 | 0.9% |
| Inflammationinflammation | 4 | 0.7% |
| Pancreatitisinflammation of the pancreas | 3 | 0.5% |
| Perforation | 3 | 0.5% |
| Blood loss | 2 | 0.4% |
| Foreign body, removal of | 2 | 0.4% |
| Injurya physical injury | 2 | 0.4% |
| Needle stick/puncture | 2 | 0.4% |
| Abscessa collection of pus | 1 | 0.2% |
| Bleeding | 1 | 0.2% |
| Cancer cells dissemination | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Echotip Procore High Definition Ultrasound Biopsy Needle | Product code FCG | All MAUDE reports |
|---|---|---|---|
| Reports | 551 | 4,933 | 26,136,888 |
| Share of that pool | — | 11.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 21.8% | 20.6% | 36.2% |
| Classified as malfunction | 78% | 78.4% | 62.3% |
| Filed by the manufacturer | 98% | 92.6% | 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 FCG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Echotip Ultra Endoscopic Ultrasound Needle | 658 | 49 | 0% |
| Magnum Needle | 448 | 206 | 0% |
| Single Use Aspiration Needle NA-U401SX | 416 | 195 | 0.2% |
| Single Use Aspiration Needle | 1,019 | 144 | 0.4% |
| EchoTip ProCore Endobronchial HD Biopsy Needle | 295 | 40 | 0% |
| Interject | 234 | 8 | 0.4% |
| Echotip Ultra Endobronchial Hd Ultrasound Needle | 194 | 24 | 0% |
| Single Use Injector | 402 | 40 | 0% |
| Olympus | 2,240 | 9 | 2.5% |
| Evolution Biliary Controlled-Release Stent - Fully Covered | 600 | 99 | 0.2% |
| Zimmon Biliary Stent Set | 530 | 34 | 0% |
| Zimmon Biliary Stent | 665 | 45 | 0% |
| Zimmon Pancreatic Stent | 211 | 6 | 0% |
| Cook | 271 | 6 | 2.2% |
| Cotton-Leung Biliary Stent | 271 | 20 | 1.1% |
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 Echotip Procore High Definition Ultrasound Biopsy Needle reports
How many FDA reports name Echotip Procore High Definition Ultrasound Biopsy Needle?
551 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 27 in the latest 12 months.
What kinds of events are reported?
malfunction (78%) and injury (21.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (26.7%), fracture (24.3%), retraction problem (18.3%), improper or incorrect procedure or method (11.8%) and material twisted/bent (11.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98%) and distributor reports (2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Echotip Procore High Definition Ultrasound Biopsy Needle 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.