MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-20 for ISOLATOR SYNERGY OLL2 A000362 manufactured by Atricure, Inc..
[2820190]
The patient was admitted for breast implant removal, mitral valve repair, and cox iv maze procedure via rt lateral thoracotomy. The right sided lesion sets were completed without any complication. Upon beginning the left atrial lesion set, the doctor observed splay between the jaws of the oll2 clamp when in the closed and locked position and requested the clamp be replaced. While the nurse was retrieving a new clamp, the doctor proceeded with the next lesion with the original clamp. The clamp was positioned to create a connecting lesion across the posterior left atrial wall. The proximal jaw of the clamp was on the epicardial surface and the distal jaw on the endocardial surface. After completing this lesion the clamp was withdrawn and the doctor observed what he classified as a small tear, or possible perforation. The area was repaired with suture and the case proceeded to completion.
Patient Sequence No: 1, Text Type: D, B5
[9982096]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003502395-2012-00004 |
| MDR Report Key | 2663774 |
| Report Source | 07 |
| Date Received | 2012-07-20 |
| Date of Report | 2012-06-21 |
| Date of Event | 2012-06-21 |
| Date Mfgr Received | 2012-06-21 |
| Device Manufacturer Date | 2012-03-27 |
| Date Added to Maude | 2012-07-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JAMES LUCKY |
| Manufacturer Street | 6217 CENTRE PARK DRIVE |
| Manufacturer City | WEST CHESTER OH 45069 |
| Manufacturer Country | US |
| Manufacturer Postal | 45069 |
| Manufacturer Phone | 5137555754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLATOR SYNERGY |
| Generic Name | ELECTROSURGICAL CUTTING/COAGULATION DEVICE |
| Product Code | OCM |
| Date Received | 2012-07-20 |
| Returned To Mfg | 2012-06-26 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 38002 |
| Device Expiration Date | 2014-03-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 6217 CENTRE PARK DRIVE WEST CHESTER OH 45069 US 45069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-20 |