MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..
[136986504]
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 at this time. There has been no serious injury ( 21 cfr 803. 3) nor would the malfunction result in a death or serious injury if it was to reoccur since the resector could not be used for the procedure. However, we have decided to report the incident since our evaluation was based on the reported defect from our distributor and the user at the hospital rather than our hands-on evaluation with this defective device itself.
Patient Sequence No: 1, Text Type: N, H10
[136986505]
During pre-use check, the blades of the resector did not rotate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00109 |
| MDR Report Key | 8294529 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-12-29 |
| Date Mfgr Received | 2019-01-01 |
| Device Manufacturer Date | 2017-12-29 |
| Date Added to Maude | 2019-01-31 |
| 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 | 2019-01-31 |
| Catalog Number | 7210387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |