MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..
[126520849]
We have received the device for evaluation. The housing and power cord were visually inspected and were found to be acceptable. The handpiece was then connected to the control unit and was further tested. The drive shaft on the handpiece did not rotate initially when the run button was pressed. However, when the run button was pressed for extended period of time, the drive shaft kept rotating even when the run button was released. We found similar issue when pressing the lock button as the drive shaft kept rotating even after releasing the lock button. The device is currently awaiting further evaluation. However, based on our device evaluation performed so far, we were able to confirm the malfunction with this device. We currently have a corrective and preventive action (capa) open to address this issue. There was no injury to the patient. The malfunction was detected prior to the case.
Patient Sequence No: 1, Text Type: N, H10
[126520850]
During pre-use check, the resector on the handpiece did not rotate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00096 |
| MDR Report Key | 8039697 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-10-06 |
| Device Manufacturer Date | 2017-06-06 |
| Date Added to Maude | 2018-11-05 |
| 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 | 2018-11-05 |
| Returned To Mfg | 2018-10-25 |
| 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 | 2018-11-05 |