MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[145138486]
We have received the complaint device for evaluation and we have confirmed the reported incident. The handpiece cable and power cable were inspected and were found to be acceptable. Handpiece was then connected into the control unit. When either the run or the window lock button was pressed, the indicator light on the control unit flashed orange indicating an issue with the handpiece and the drive shaft would not turn. Upon disassembly, we did not observe any component failure. However, the seal housing was observed to have heat discoloration. The likely root cause of this issue is a seized ball bearing. Over time, particulates and water could enter into the ball bearing assembly since it is not a hermatically sealed component. We have already implemented a corrective and preventive action (capa) to resolve this issue by replacing the ball bearings with slip bearings which better prevent the bearings from corrosion and from seizing. This device was manufactured prior to the implementation of these changes. There was no harm to the patient as the result of this incident. The procedure was completed using a different handpiece.
Patient Sequence No: 1, Text Type: N, H10
[145138487]
The resector failed to rotate during pre-use check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00055 |
| MDR Report Key | 8597023 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-05-09 |
| 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 | 2019-05-09 |
| Returned To Mfg | 2019-04-17 |
| Catalog Number | 7210387F |
| Lot Number | YB02177 |
| 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 | 2019-05-09 |