MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[145772964]
We have received the device for evaluation. The housing and powercord were visually inspected and were found to be acceptable. The handpiece was then connected to a control unit. The drive shaft rotated properly when the run or the window lock button were pressed. We were unable to replicate the reported intermittent failure with this device as it operated properly in all speeds and settings during our evaluation. Upon further inspection, we noted black marker lines on the handpiece's connector end suggesting that the user may have removed the power cord at some point. Upon disassembly, there were no signs of component malfunction or assembly error. There was no injury to the patient as the result of the device nor did this incident resulted in any significant delay in the procedure. Surgeon was able to complete the procedure by changing to a different handpiece. At this time, we could not conclusively determine the root cause of the defect as we were unable to replicate the reported failure. It is possible that there was a high current surge in the handpiece during the procedure. This device is programmed with a safety feature that allows it to stop rotating when a high current flow is detected in the circuit.
Patient Sequence No: 1, Text Type: N, H10
[145772965]
Surgeon reported that during the transilluminated phlebectomy (tipp) procedure, the handpiece worked intermittently. He then switched to another handpiece to complete the procedure. There was no injury to the patient as the result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00051 |
| MDR Report Key | 8573479 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-05-02 |
| 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 | 2019-05-02 |
| Returned To Mfg | 2019-04-15 |
| 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 | 2019-05-02 |