MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[145771827]
We have received the complaint device for evaluation. The housing and powercord were visually inspected and found to be acceptable. The handpiece was ran for several minutes. However, we could not replicate the reported defect. However, during our evaluation, the drive shaft was rotating intermittently even after releasing the run or the window lock button. Upon disassembly, we observed water inside the core tube. The seal housing also had visual signs of heat discoloration which suggests that the device was overheated at some point. The root cause was determined to be a seal failure that led to water ingress into the handpiece, which adversely affected the motor functionality. We currently have a capa open to address this issue. The corrective action includes repairs by replacing the current seal housing with a new seal housing assembly, o-rings and switch pcb and motor if there is any evidence of water inside the core tube. We believe these changes will better prevent water and steam from entering into the inner components of the handpiece. Device was not used for the procedure. Procedure was completed using another handpiece that they had in stock.
Patient Sequence No: 1, Text Type: N, H10
[145771828]
During pre-use check, the handpiece was overheating. Device was not used for the tipp procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00041 |
| MDR Report Key | 8505541 |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-15 |
| Date Added to Maude | 2019-04-11 |
| 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 | 0 |
| Brand Name | TRIVEX SYSTEM RESECTOR HANDPIECE |
| Generic Name | VARICOSE VEIN ALBATION SYSTEM |
| Product Code | DWQ |
| Date Received | 2019-04-11 |
| Returned To Mfg | 2019-03-18 |
| 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 | 2019-04-11 |