MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-28 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..
[125795363]
We have received the device for evaluation. The mdu housing was visually inspected and was found to be acceptable. Upon further inspection of the connector of the handpiece and the power cable, we observed rust which suggests presence of moisture inside the connector. The drive shaft rotated properly on all settings and speeds. Upon disassembly of the housing, we observed water inside the core tube and under the pc board. The heat sink was observed to have stuck together with the core tube due to corrosion. The root cause of the issue was determined to be damage to inner components of the handpiece due to water ingress. It is possible that the device handling technique and improper sterilization process at the hospital could have contributed to this incident. Our ifu clearly states not to remove the cable from the handpiece and secure the cable end with the protective cap during sterilization. We currently also have a corrective and preventive action (capa) to address this issue. There was no injury to the patient as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[125795364]
The handpiece failed to operate during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00089 |
| MDR Report Key | 8011462 |
| Date Received | 2018-10-28 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-09-27 |
| Date Added to Maude | 2018-10-28 |
| 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 | 2018-10-28 |
| Returned To Mfg | 2018-10-03 |
| 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 | 2018-10-28 |