MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-14 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..
[185004555]
We have not received the device for "evalution". Hence, we could not conclusively determine the root cause of the malfunction at this time.
Patient Sequence No: 1, Text Type: N, H10
[185004556]
During pre-use check, the handpiece failed to operate properly. The blade rotated intermittently even when the run button was not pressed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00019 |
| MDR Report Key | 9714615 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-16 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2212266152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIVEX SYSTEM RESECTOR HANDPIECE |
| Generic Name | HANDPIECE |
| Product Code | DWQ |
| Date Received | 2020-02-14 |
| Model Number | 7210387F |
| Catalog Number | 7210387F |
| Lot Number | YB02303 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |