MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for TRIVEX SYSTEM RESECTOR HANDPIECE 7201387F manufactured by Lemaitre Vascular, Inc..
[130636236]
We have not received the device for evaluation since the device is still at the hospital. However, we have confirmed the reported incident based on the video of the defect that was provided to us by the hospital. The blades kept rotating slowly even though the window lock button was not pressed. 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.
Patient Sequence No: 1, Text Type: N, H10
[130636237]
The resector of the handpiece kept rotating although the window lock button was not pressed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00109 |
| MDR Report Key | 8165810 |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-12-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-12-14 |
| Catalog Number | 7201387F |
| 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 | 2018-12-14 |