MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-01 for TRIVEX SYSTEM RESECTOR HANDPIECE 7201387 manufactured by Lemaitre Vascular, Inc..
[129580103]
We have not received the device for evaluation since the device is still at the hospital. Hence, we could not conclusively determine the root cause of the defect. There was no impact on the patient's health as the result of this incident. The issue was detected during the pre-use check and the procedure was completed using a different handpiece in stock. The device was non-functional and therefore the malfunction was detected prior to the case. There has been no serious injury (section 2. 13) nor would the malfunction result in a death or serious injury if it was to reoccur i. E the device never functioned at any point of the case and therefore the patient was never exposed or potentially exposed, to the device. However, we have decided to report the incident since our evaluation was based on the reported defect from our sales rep. And the user at the hospital rather than our hands-on evaluation with this defective device itself. Our sales rep. Reached out to the team involved in the surgery for additional information. However, neither the surgeon or the tech was available for discussion on this case at the time.
Patient Sequence No: 1, Text Type: N, H10
[129580104]
The control unit displayed an error code when the resector was plugged into the control unit. The control unit was flashing orange upon connection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00102 |
| MDR Report Key | 8122019 |
| Date Received | 2018-12-01 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2017-06-06 |
| Date Added to Maude | 2018-12-01 |
| 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 | 2018-12-01 |
| Catalog Number | 7201387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-12-01 |