MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-26 for LUMITIP MID1 manufactured by Atricure, Inc..
[43631592]
Patient Sequence No: 1, Text Type: N, H10
[43631593]
The tech tried to active the light but it would not work. A second mid1 was opened to complete procedure. Manufacturer response for atricure articulating dissection instrument, atricure wolf lumitip (per site reporter) manufacturer provided rga# for product return evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5607251 |
| MDR Report Key | 5607251 |
| Date Received | 2016-04-26 |
| Date of Report | 2016-04-20 |
| Date of Event | 2016-04-08 |
| Report Date | 2016-04-20 |
| Date Reported to FDA | 2016-04-20 |
| Date Reported to Mfgr | 2016-04-20 |
| Date Added to Maude | 2016-04-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMITIP |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2016-04-26 |
| Returned To Mfg | 2016-04-20 |
| Catalog Number | MID1 |
| Lot Number | 56514 |
| Device Expiration Date | 2018-03-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-26 |