MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210387 manufactured by Lemaitre Vascular, Inc..
[119498837]
We have received the device for evaluation. However, we were unable to replicate the reported defect. Device was found to operate properly when the run or the window lock button was pressed. Upon disassembly of the housing, we found moisture in the inner assembly. Although we are inconclusive about the root cause of the defect, it is possible that the resector did not make proper connection with the control unit situated at the hospital. There was no impact on the patient's health as the result of this incident. Procedure was completed using a different handpiece.
Patient Sequence No: 1, Text Type: N, H10
[119498838]
During pre-use check, the blades of the resector failed to rotate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00063 |
| MDR Report Key | 7839630 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2015-07-15 |
| Date Added to Maude | 2018-08-31 |
| 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 CONTROL UNIT WITH BUILT IN PUMP |
| Generic Name | HANDPIECE |
| Product Code | DWQ |
| Date Received | 2018-08-31 |
| Returned To Mfg | 2018-07-19 |
| 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 | 1. Death | 2018-08-31 |