MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for TRIVEX SYSTEM RESECTOR HANDPIECE 7201387 manufactured by Lemaitre Vascular, Inc..
[128050825]
We have received the device for evaluation. The mdu housing and power cord were visually inspected and were found to be acceptable. The drive shaft rotated slightly when the run button was pressed but did not rotate to their full speed. We could not disassemble the core tube at this time as one of the end bell pins requires machining in order to be removed. The drive shaft did not rotate when we tried to rotate the drive shaft using the force with our hand, which indicates that the ball bearings might have seized in this device, which could have led to this issue. We have already implemented a corrective and preventive action (capa) to resolve this issue by replacing the ball bearings with slip bearings. This device was manufactured prior to the implementation of these changes. There was no injury to the patient since the issue was detected during pre-use check. The procedure was completed using a different handpiece.
Patient Sequence No: 1, Text Type: N, H10
[128050826]
During pre-use check, the handpiece failed to operate when it was connected to the control unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00099 |
| MDR Report Key | 8091953 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2018-11-20 |
| 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 | 2018-11-20 |
| Returned To Mfg | 2018-11-06 |
| Catalog Number | 7201387 |
| 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 | 2018-11-20 |