MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-15 for ATRICURE CRYO MODULE SYSTEM ACM1 A000702 manufactured by Atricure Inc..
[28294644]
(b)(4). The device was not returned to atricure for evaluation and the lot number of the device was unable to be ascertained.
Patient Sequence No: 1, Text Type: N, H10
[28294685]
The sales rep. Stated that on (b)(4) 2015, she was notified by the account that after the surgical procedure was completed, the nurse attempted to vent the system by pulling the red pressure relief knob on the back of the unit, while performing this venting operation, she inadvertently touched one of the black filter canisters located on the back of the unit. Since the filter canister had a buildup of frost on it, the nurse received a cryo blister to her hand. There was no patient involvement. A follow up visit revealed that the nurse's hand healed and that there was no additional consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2015-00039 |
| MDR Report Key | 5151675 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-15 |
| Date of Report | 2015-09-17 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-09-17 |
| Date Added to Maude | 2015-10-15 |
| 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. JOHN HUFF |
| Manufacturer Street | 6217 CENTRE PARK DRIVE |
| Manufacturer City | WEST CHESTER OH 450693886 |
| Manufacturer Country | US |
| Manufacturer Postal | 450693886 |
| Manufacturer Phone | 5136444725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRICURE CRYO MODULE SYSTEM |
| Generic Name | CRYOICE CRYOSURGICAL CONSOLE |
| Product Code | GXH |
| Date Received | 2015-10-15 |
| Model Number | ACM1 |
| Catalog Number | A000702 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE INC. |
| Manufacturer Address | 6217 CENTRE PARK DRIVE WEST CHESTER OH 450693886 US 450693886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-15 |