MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-03-09 for TRIDENT ENDOSCOPIC ULTRASOUND BIOPSY NEEDLE(FNB) EUS-22-1-N manufactured by Micro-tech(nanjing) Co.,ltd..
[102092040]
Corrective action and preventive action: we will modify the design drawings to shorten the length of the developing area of the needle point engraving and avoid the force position of the pliers. -due date 03/29/2018. We will modify the inspection drawings, strengthen the toughness of the tube in the area of the needle point carving, and reduce the risk of the bad products entering the production -due date 04/16/2018.
Patient Sequence No: 1, Text Type: N, H10
[102092041]
Pre-market evaluation: clinician used competitive device that could not puncture tumor. They used micro-tech eus-fnb and were able to puncture. They went in a 2nd time with the same micro-tech needle to biopsy and when pulling the eus out, the needle had broken off and lodged into a side of the pancreas. The staff tried to remove the needle with forceps, but were unable to. The patient was admitted into a local hospital to have it removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004837686-2018-00001 |
| MDR Report Key | 7327666 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-02-14 |
| Device Manufacturer Date | 2017-12-26 |
| Date Added to Maude | 2018-03-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS BECKY LI |
| Manufacturer Street | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU |
| Manufacturer City | NANJING, JIANG SU 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal | 210032 |
| Manufacturer G1 | MICRO-TECH(NANJING) CO.,LTD. |
| Manufacturer Street | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU |
| Manufacturer City | NANJING, JIANG SU 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 210032 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIDENT ENDOSCOPIC ULTRASOUND BIOPSY NEEDLE(FNB) |
| Generic Name | ENDOSCOPIC ULTRASOUND NEEDLE |
| Product Code | ODG |
| Date Received | 2018-03-09 |
| Returned To Mfg | 2018-02-23 |
| Catalog Number | EUS-22-1-N |
| Lot Number | M171226171 |
| Device Expiration Date | 2019-12-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO-TECH(NANJING) CO.,LTD. |
| Manufacturer Address | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU NANJING, JIANG SU 210032 CH 210032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-03-09 |