MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..
[125795385]
We have received the device for evaluation. We observed that the run button and the hermetic header assembly had been removed from the bezel and housing. Some of the wires that connect the motor and other components to the end bell connector pins had been disconnected and some of the wires were missing the heat shrink. Based on the condition the device was received, it is likely the device was manipulated with some attempt to repair. The resector would not rotate and the surgeon would not be able to use this device for the phlebectomy procedure. Based on the limited available information we have at this time, we are reporting this incident as we do not have adequate information about how the device was handled after the event at the user facility. There was no injury to the patient as the result of this incident since the issue was detected during pre-use check. The procedure was completed using another handpiece that they have in stock.
Patient Sequence No: 1, Text Type: N, H10
[125795386]
During pre-use check, the blades of the resector did not spin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00091 |
| MDR Report Key | 8021529 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-09-30 |
| Date Mfgr Received | 2018-09-30 |
| Device Manufacturer Date | 2017-12-29 |
| Date Added to Maude | 2018-10-30 |
| 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 | HANDPIECE |
| Product Code | DWQ |
| Date Received | 2018-10-30 |
| Returned To Mfg | 2018-10-30 |
| Catalog Number | 7210387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-10-30 |