MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-10 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[134329776]
We have received the complaint device for evaluation. However, we were unable to replicate the reported defect during our evaluation. The housing and power cord of the handpiece were visually inspected and were found to be acceptable. The indicator light in the control unit flashed steady green indicating the handpiece was functional. The device was found to be operating properly on all speeds and settings. Upon disassembly of the core tube, we did not observe any moisture inside the core tube. The seal housing appeared to be very clean and was unlikely to have been used in any procedure. Device was not used for the procedure. Procedure was completed using another handpiece that they have in stock.
Patient Sequence No: 1, Text Type: N, H10
[134329777]
During pre-use check, the handpiece failed to operate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00004 |
| MDR Report Key | 8232999 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2017-12-29 |
| Date Added to Maude | 2019-01-10 |
| 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 | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIVEX SYSTEM RESECTOR HANDPIECE |
| Generic Name | VARICOSE VEIN ALBATION SYSTEM |
| Product Code | DWQ |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2018-12-31 |
| Catalog Number | 7210387F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 02148 US 02148 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |