Device brand name · Fcg kit needle biopsy
EchoTip ProCore Endobronchial HD Biopsy Needle: medical device reports filed with FDA
295 reports name it, 2016–2026. Manufacturer given most often on reports: Cook Ireland. Product code FCG.
- 295
- device reports naming the brand
- 0% of all MAUDE reports · about 30 a year
- 40
- reports, 12 months to August 2026
- 16 in the 12 months before
- 58.6%
- classified as malfunction
- 78.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 295 reports that name the brand "EchoTip ProCore Endobronchial HD Biopsy Needle" (fcg kit needle biopsy), received between August 2016 and June 2026; the manufacturer given most often on reports is Cook Ireland. Spellings of one product vary from report to report.
40 reports arrived in the 12 months to August 2026, up 150% from 16 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 (58.6%) and injury (41.4%); 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 (30.2%), fracture (28.1%) and improper or incorrect procedure or method (15.9%). The patient problems coded most often are foreign body in patient, hemorrhage/blood loss/bleeding and device embedded in tissue or plaque. 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 | 89 | 30.2% | 26.5% |
| Fracturea broken bone | 83 | 28.1% | 8.5% |
| Improper or incorrect procedure or method | 47 | 15.9% | 4.6% |
| Material twisted/bent | 30 | 10.2% | 7.9% |
| Retraction problem | 25 | 8.5% | 6.7% |
| Bent | 20 | 6.8% | 3.4% |
| Kinkedthe tube or line kinked | 17 | 5.8% | 1.6% |
| Physical resistance/sticking | 16 | 5.4% | 2.4% |
| Material perforation | 10 | 3.4% | 1.6% |
| Difficult to open or close | 6 | 2% | 0.5% |
| Difficult to advance | 5 | 1.7% | 1.3% |
| Off-label use | 5 | 1.7% | 3.3% |
| Activation, positioning or separation problem | 4 | 1.4% | 0.2% |
| Material deformation | 4 | 1.4% | 1.1% |
| Detachment of device or device componentpart of the device came off | 3 | 1% | 4% |
| Failure to advance | 3 | 1% | 1.3% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.7% | 0.5% |
| Material separation | 2 | 0.7% | 1.8% |
| Unintended movement | 2 | 0.7% | 0.2% |
| Device damaged by another device | 1 | 0.3% | 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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 96 | 32.5% |
| Hemorrhage/blood loss/bleeding | 3 | 1% |
| Device embedded in tissue or plaque | 2 | 0.7% |
| Pulmonary emphysema | 2 | 0.7% |
| Gastrointestinal hemorrhage | 1 | 0.3% |
| Mediastinal shift | 1 | 0.3% |
| No patient involvement | 1 | 0.3% |
| Perforation | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | EchoTip ProCore Endobronchial HD Biopsy Needle | Product code FCG | All MAUDE reports |
|---|---|---|---|
| Reports | 295 | 4,933 | 26,136,888 |
| Share of that pool | — | 6% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 41.4% | 20.6% | 36.2% |
| Classified as malfunction | 58.6% | 78.4% | 62.3% |
| Filed by the manufacturer | 94.6% | 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% |
| Echotip Procore High Definition Ultrasound Biopsy Needle | 551 | 27 | 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% |
| 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 Endobronchial HD Biopsy Needle reports
How many FDA reports name EchoTip ProCore Endobronchial HD Biopsy Needle?
295 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 40 in the latest 12 months.
What kinds of events are reported?
malfunction (58.6%) and injury (41.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (30.2%), fracture (28.1%), improper or incorrect procedure or method (15.9%), material twisted/bent (10.2%) and retraction problem (8.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (94.6%) and distributor reports (5.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that EchoTip ProCore Endobronchial HD 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.