MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210386F manufactured by Lemaitre Vascular, Inc..
[123537727]
We have received the device for evaluation and we have confirmed the reported incident. Initially, we observed the control unit to operate on all settings and functions. However, upon further testing, we noticed a hesitation in the operation of the resector and observed that the harness connector was loose. The connector was most likely damaged by the operator while moving the resector power cable negligently or during insertion/removal of the resector power cable into the control unit. A loose connector can cause intermittent connection and can cause the handpiece to operate intermittently. There was no injury to the patient. The issue was detected during pre-use check and the procedure was completed using a different control unit.
Patient Sequence No: 1, Text Type: N, H10
[123537728]
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 | 1220948-2018-00079 |
| MDR Report Key | 7957433 |
| Date Received | 2018-10-11 |
| Date of Report | 2011-10-11 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-11 |
| Date Added to Maude | 2018-10-11 |
| 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 CONTROL UNIT WITH BUILT IN PUMP |
| Generic Name | VARICOSE VEIN ALBATION SYSTEM |
| Product Code | DWQ |
| Date Received | 2018-10-11 |
| Returned To Mfg | 2018-09-17 |
| Catalog Number | 7210386F |
| 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 | 2018-10-11 |