MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[142783666]
We have received the complaint device for evaluation. However, we were unable to confirm the reported incident as we were unable to replicate the reported incident during our evaluation. The housing and power cord were visually inspected and were found acceptable. The indicator on the control unit properly flashed solid green when the handpiece was connected to the control unit. The device properly functioned on all settings and speed. Upon disassembly, water was observed inside the core tube. The root cause was determined to be a seal failure that led to water ingress into the handpiece, which intermittently 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. Procedure was completed using another handpiece that they had in stock.
Patient Sequence No: 1, Text Type: N, H10
[142783667]
During tipp ( transilluminated powered phlebectomy) procedure, the resector failed to rotate. So, the procedure was completely using a different handpiece. There was no injury or any adverse event to the patient as the result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00044 |
| MDR Report Key | 8532737 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-04-19 |
| 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 | 2019-04-19 |
| Returned To Mfg | 2019-04-01 |
| Catalog Number | 7210387F |
| Lot Number | YB02407 |
| 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 | 2019-04-19 |