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..
[125440887]
We have received the device for evaluation. The drive shaft rotated properly when the run button was pressed. The drive shaft rotated properly when the lock button was pressed initially but stopped rotating after few seconds. Further inspection found a small amount of moisture in the core tube and under the pc board. The drive shaft rotated properly when the motor was tested in a standalone mode when either of the buttons were pressed. The drive shaft was found to be stuck to the ball bearing due to corrosion. The moisture caused the ball bearing to corrode over time until the motor could not rotate the drive shaft anymore. 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 intermittently affected the motor functionality. Our ifu states not to remove the cable from the handpiece and secure the cable end with the protective cap during sterilization. We currently have a corrective and preventive action ( capa ) open to address this issue. The issue was detected during pre-use check. Procedure was completed using a different handpiece.
Patient Sequence No: 1, Text Type: N, H10
[125440888]
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 | 1220948-2018-00088 |
| MDR Report Key | 8011448 |
| Date Received | 2018-10-28 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-09-26 |
| 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 | 2018-10-05 |
| 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 |