MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for SINGLE-USE BIOPSY FORCEPS NBF03-11023230 manufactured by Micro-tech(nanjing) Co.,ltd.
[112572837]
Short-term corrective actions: the tension tube defect has been made known to the supplier, the supplier has designed a new fixture to remove unqualified tension tubes in their process. -- (b)(4) (completed). Train operators to check whether the tension tube can be assembled, and if not, the defective product should be removed immediately. On 2018-05-30 (b)(4) (completed) permanent corrective actions: in order to better improve customer experience, and foolproof design, change the design of the tension tube to make the t-shaped tension tube. If the length of the tension tube exceeds the tolerance, the tension tube would not fit into the slider after the tension tube is assembled with the tension block. This redesign reduces the criticality of the dimension. The design change introduces no additional contact points and no new risks. Initial tensile testing of all (b)(4) samples made was greater than 100n and resulting in a cpk of 2. 95, which met the requirements. (b)(4) 2018-07-30 (to be completed).
Patient Sequence No: 1, Text Type: N, H10
[112572838]
Micro-tech (nanjing) co. ,ltd. Received a complaint on its forceps from (b)(6) on march 3, 2018. It was reported by the doctor that the product did not close during case, and it was necessary to withdrawal the device in the open position. The only was to close it was to manually force it closed. This submission does not, in our opinion, pose any serious risk to a patient or user, but we are considering it an mdr based on it being an adverse event that needs to be reported to (b)(6). Micro-tech communicated with (b)(6) for the samples to be sent back. Micro-tech (nanjing) co. ,ltd. Received the complaint sample (qty:1) on may 23, 2018. Micro-tech (nanjing) co. ,ltd is reporting this adverse event to the fda, as this product is also sold in the united states.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004837686-2018-00002 |
| MDR Report Key | 7628759 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-22 |
| Date of Event | 2017-06-10 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2017-02-16 |
| Date Added to Maude | 2018-06-22 |
| 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, JIANGSU 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, JIANGSU 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 210032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SINGLE-USE BIOPSY FORCEPS |
| Generic Name | SINGLE-USE BIOPSY FORCEPS |
| Product Code | KGE |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-05-23 |
| Model Number | NBF03-11023230 |
| Lot Number | B170216001 |
| 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, JIANGSU 210032 CH 210032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-22 |