MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for SYNERGY? ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[141934698]
Per surgeon, isolator not working as it should. Waveform on energy source screen going up, then dropping off, then going up again, which is not indicative of a successful ablation/burn. Surgeon attempted x2, then asked for a new device. The second device worked without issue on the same atricure power source.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8513834 |
| MDR Report Key | 8513834 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-03 |
| Date of Event | 2018-11-08 |
| Report Date | 2019-04-03 |
| Date Reported to FDA | 2019-04-03 |
| Date Reported to Mfgr | 2019-04-15 |
| Date Added to Maude | 2019-04-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | SYNERGY? ABLATION SYSTEM |
| Generic Name | SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code | OCM |
| Date Received | 2019-04-15 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 86353 |
| Device Availability | Y |
| Device Age | 1 DA |
| 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 | 2019-04-15 |