Device brand name · Single use aspiration needle
Single Use Aspiration Needle NA-U401SX: medical device reports filed with FDA
416 reports name it, 2017–2026. Manufacturer given most often on reports: Aomori Olympus. Product code FCG.
- 416
- device reports naming the brand
- 0% of all MAUDE reports · about 46 a year
- 195
- reports, 12 months to August 2026
- 56 in the 12 months before
- 80.8%
- classified as malfunction
- 78.4% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
416 medical device reports received by FDA name the brand "Single Use Aspiration Needle NA-U401SX" (single use aspiration needle); the manufacturer given most often on reports is Aomori Olympus; received from June 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
195 reports arrived in the 12 months to August 2026, up 248% from 56 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 (80.8%), injury (19%) and death (0.2%); 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 (29.6%), detachment of device or device component (10.3%) and material split, cut or torn (6.7%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque and appropriate clinical signs, symptoms and conditions term/code not available. 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 | 123 | 29.6% | 26.5% |
| Detachment of device or device componentpart of the device came off | 43 | 10.3% | 4% |
| Material split, cut or torn | 28 | 6.7% | 1.1% |
| Material puncture/hole | 24 | 5.8% | 1.3% |
| Material twisted/bent | 24 | 5.8% | 7.9% |
| Mechanical problema mechanical problem | 17 | 4.1% | 1% |
| Material perforation | 13 | 3.1% | 1.6% |
| Material separation | 12 | 2.9% | 1.8% |
| Difficult to advance | 11 | 2.6% | 1.3% |
| Material integrity problema problem with the device material | 10 | 2.4% | 0.5% |
| Retraction problem | 10 | 2.4% | 6.7% |
| Mechanical jam | 9 | 2.2% | 0.4% |
| Material deformation | 8 | 1.9% | 1.1% |
| Material frayed | 7 | 1.7% | 0.2% |
| Fracturea broken bone | 6 | 1.4% | 8.5% |
| Unintended movement | 6 | 1.4% | 0.2% |
| Device damaged by another device | 5 | 1.2% | 0.2% |
| Leak/splashthe device leaked | 5 | 1.2% | 0.2% |
| Activation failure | 4 | 1% | 0.1% |
| Failure to advance | 4 | 1% | 1.3% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 15 | 3.6% |
| Device embedded in tissue or plaque | 5 | 1.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 1% |
| Hemorrhage/blood loss/bleeding | 4 | 1% |
| Blood loss | 2 | 0.5% |
| Needle stick/puncture | 2 | 0.5% |
| Pneumothoraxa collapsed lung | 2 | 0.5% |
| Upper respiratory tract injury | 2 | 0.5% |
| Abscessa collection of pus | 1 | 0.2% |
| Chest painchest pain | 1 | 0.2% |
| Confusion/ disorientation | 1 | 0.2% |
| Coughcough | 1 | 0.2% |
| Exposure to body fluids | 1 | 0.2% |
| Fever | 1 | 0.2% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Single Use Aspiration Needle NA-U401SX | Product code FCG | All MAUDE reports |
|---|---|---|---|
| Reports | 416 | 4,933 | 26,136,888 |
| Share of that pool | — | 8.4% | 0% |
| Classified as death, per 1,000 reports | 2 | 5 | 9 |
| Classified as injury | 19% | 20.6% | 36.2% |
| Classified as malfunction | 80.8% | 78.4% | 62.3% |
| Filed by the manufacturer | 91.8% | 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 | 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 Single Use Aspiration Needle NA-U401SX reports
How many FDA reports name Single Use Aspiration Needle NA-U401SX?
416 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 195 in the latest 12 months.
What kinds of events are reported?
malfunction (80.8%), injury (19%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (29.6%), detachment of device or device component (10.3%), material split, cut or torn (6.7%), material puncture/hole (5.8%) and material twisted/bent (5.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (91.8%) and distributor reports (3.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Single Use Aspiration Needle NA-U401SX 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.