MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210387 manufactured by Lemaitre Vascular, Inc..
[122304380]
We have received the device for evaluation. The device did not operate at all when we tested the device during our evaluation. Further inspection found that a wire had detached from the pcb and a seal housing was found to be out of alignment with the heatsink tank. The seal housing was not tightly coupled to the motor which allowed the seal housing/motor to rotate enough to cause the wire to break. We believe this was an assembly error isolated to just this handpiece. There was no injury to the patient as the result of this incident. However, surgeon had to abandon the phlebectomy surgery as a result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[122304381]
Blade rotated intermittently during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00074 |
| MDR Report Key | 7918715 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2017-07-17 |
| Date Added to Maude | 2018-09-28 |
| 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 CONTROL UNIT WITH BUILT IN PUMP |
| Generic Name | HANDPIECE |
| Product Code | DWQ |
| Date Received | 2018-09-28 |
| Returned To Mfg | 2018-09-06 |
| Catalog Number | 7210387 |
| 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 | 2018-09-28 |