Device brand name · Fcg kit needle biopsy
Echotip Ultra Endoscopic Ultrasound Needle: medical device reports filed with FDA
658 reports name it, 2010–2026. Manufacturer given most often on reports: Cook Ireland. Product code FCG.
- 658
- device reports naming the brand
- 0% of all MAUDE reports · about 41 a year
- 49
- reports, 12 months to August 2026
- 55 in the 12 months before
- 91.2%
- classified as malfunction
- 78.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
658 medical device reports received by FDA name the brand "Echotip Ultra Endoscopic Ultrasound Needle" (fcg kit needle biopsy); the manufacturer given most often on reports is Cook Ireland; received from April 2010 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
49 reports arrived in the 12 months to August 2026, down 11% from 55 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 (91.2%) and injury (8.8%); 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 (22%), material twisted/bent (21.9%) and off-label use (19.1%). The patient problems coded most often are hemorrhage/blood loss/bleeding, foreign body in patient 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 | 145 | 22% | 26.5% |
| Material twisted/bent | 144 | 21.9% | 7.9% |
| Off-label use | 126 | 19.1% | 3.3% |
| Fracturea broken bone | 99 | 15% | 8.5% |
| Retraction problem | 76 | 11.6% | 6.7% |
| Bent | 51 | 7.8% | 3.4% |
| Improper or incorrect procedure or method | 35 | 5.3% | 4.6% |
| Physical resistance/sticking | 26 | 4% | 2.4% |
| Material perforation | 23 | 3.5% | 1.6% |
| Device damaged prior to usethe device was damaged before use | 15 | 2.3% | 0.5% |
| Kinkedthe tube or line kinked | 15 | 2.3% | 1.6% |
| Material deformation | 15 | 2.3% | 1.1% |
| Structural problem | 13 | 2% | 0.4% |
| Dent in material | 11 | 1.7% | 0.4% |
| Difficult to advance | 11 | 1.7% | 1.3% |
| Difficult to removethe device was hard to remove | 8 | 1.2% | 3% |
| Material fragmentation | 6 | 0.9% | 0.6% |
| Difficult to insertthe device was hard to insert | 4 | 0.6% | 0.7% |
| Failure to advance | 4 | 0.6% | 1.3% |
| Loss of or failure to bond | 4 | 0.6% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 19 | 2.9% |
| Foreign body in patientpart of a device left in the patient | 17 | 2.6% |
| Gastrointestinal hemorrhage | 11 | 1.7% |
| Fever | 7 | 1.1% |
| Pancreatitisinflammation of the pancreas | 7 | 1.1% |
| No patient involvement | 6 | 0.9% |
| Abdominal painstomach or belly pain | 4 | 0.6% |
| Painpain, site not specified | 4 | 0.6% |
| Biliary cirrhosis | 2 | 0.3% |
| Foreign body, removal of | 2 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.2% |
| Discomfortdiscomfort | 1 | 0.2% |
| Injurya physical injury | 1 | 0.2% |
| Liver damage/dysfunction | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Echotip Ultra Endoscopic Ultrasound Needle | Product code FCG | All MAUDE reports |
|---|---|---|---|
| Reports | 658 | 4,933 | 26,136,888 |
| Share of that pool | — | 13.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 8.8% | 20.6% | 36.2% |
| Classified as malfunction | 91.2% | 78.4% | 62.3% |
| Filed by the manufacturer | 99.7% | 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 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% |
| 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 Ultra Endoscopic Ultrasound Needle reports
How many FDA reports name Echotip Ultra Endoscopic Ultrasound Needle?
658 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 49 in the latest 12 months.
What kinds of events are reported?
malfunction (91.2%) and injury (8.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (22%), material twisted/bent (21.9%), off-label use (19.1%), fracture (15%) and retraction problem (11.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and distributor reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Echotip Ultra Endoscopic Ultrasound 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.