MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..
[127075626]
We have received the device for evaluation. The housing and power cord were visually inspected and were found to be acceptable. The handpiece status light flashed green when the device was connected to the control unit indicating an issue with the handpiece. The drive shaft did not rotate when the window lock button was pressed. However, the drive shaft rotated properly when the run button was pressed. Upon disassembly of the housing, water was observed inside the core tube. The window lock reed switch on the switch pc board was also found to be malfunctioning. The root cause of the defect was determined to be a damage to the pc board due to water exposure. We currently have a corrective and preventive action (capa) open to address this issue. There was no injury to the patient. The malfunction was detected prior to the case.
Patient Sequence No: 1, Text Type: N, H10
[127075627]
During pre-use check, the resector on the handpiece did not rotate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00098 |
| MDR Report Key | 8056680 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-11-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HANDPIECE |
| Product Code | DWQ |
| Date Received | 2018-11-09 |
| Returned To Mfg | 2018-10-18 |
| Catalog Number | 7210387 |
| 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 | 2018-11-09 |