MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[126513221]
We have received the device for evaluation. When the handpiece was connected to the control unit, it flashed green indicating an issue with the handpiece. Upon disassembly, water was observed inside the core tube and under the pc board. The switch assembly area was found to be acceptable. When the motor was tested in a standalone mode, the lock reed switch was activated but the motor rotated hesitantly suggesting some drag inside the motor. This extra drag could have prevented the mdu drive shaft from rotating when the motor was operating under a load - with the mdu drive shaft and the resector connected at the user facility. The root cause of the issue was determined to be a motor damage due to water ingress. The seal failure was likely due to wear from repeated cleaning, use and sterilization that led to water ingress into the inner components of the handpiece that affected the motor functionality. 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. The device never functioned at any point of the case and therefore the patient was never exposed to the device.
Patient Sequence No: 1, Text Type: N, H10
[126513222]
During pre-use check, the resector on the handpiece did not spin at all when pressing either the run or the window lock button.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00095 |
| MDR Report Key | 8030752 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2018-11-01 |
| 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 | HANDPIECE |
| Product Code | DWQ |
| Date Received | 2018-11-01 |
| Returned To Mfg | 2018-10-05 |
| 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 | 2018-11-01 |