Home › Micro-Tech (Nanjing) Co., Ltd. › Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)
Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)
Micro-Tech (Nanjing) Co., Ltd. · Model EUS-19-1-FS1 · UDI-DI 06932503534697
FCG
Prescription
1
510(k) clearances
4,892
Adverse events (27 deaths)
54
Recalls
129
Facilities
Description
Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm, FNB needle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-02 | Bard Peripheral Vascular Inc | Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2024-04-01 | Cook Medical Incorporated | Devices may contain elevated levels of bacterial endotoxin. |
| 2024-04-01 | Cook Medical Incorporated | Devices may contain elevated levels of bacterial endotoxin. |
| 2023-03-31 | Olympus Corporation of the Americas | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during need |
| 2023-03-31 | Olympus Corporation of the Americas | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during need |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.