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..
[122306913]
We have received the device for evaluation and we were able to confirm the reported incident. The blade rotated multiple cycles after the run button was released. Upon disassembly of the handpiece, we found all of the inner components in proper working condition. However, we noticed the cable attached to the handpiece was damaged which could have caused the device to malfunction. The damage was likely a result of mishandling and damage at the user facility. 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
[122306914]
Blade rotated intermittently during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00073 |
| MDR Report Key | 7918717 |
| 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 | 2017-05-23 |
| 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 |