MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[132570188]
We have received the device for evaluation and we have confirmed the reported incident. The status light on the control unit flashed orange when the handpiece was connected into the control unit indicating an issue with the handpiece. The drive shaft did not rotate at all when either the window lock or the run button was pressed. Further inspection found a small amount of moisture in the core tube. It is likely the water ingress inside the core tube damaged the electrical components inside the handpiece affecting the motor functionality. We currently have a corrective and preventive action (capa) open to address this issue. There was no injury to the patient as the result of this incident. Surgeon performed stab phlebectomy to complete the surgery.
Patient Sequence No: 1, Text Type: N, H10
[132570189]
During the transilluminated powered phlebectomy procedure (tipp), the handpiece stopped working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00001 |
| MDR Report Key | 8210315 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-11-03 |
| Date Added to Maude | 2019-01-02 |
| 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 | 2019-01-02 |
| Returned To Mfg | 2018-12-28 |
| Catalog Number | 7210387F |
| 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 | 2019-01-02 |