MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-02-26 for ATRICURE CRYO MODULE SYSTEM ACM V6 A000898 manufactured by Atricure, Inc.
[39202020]
Complaint number: (b)(4). The unit was not returned for evaluation. Pursuant to atricure's internal processes, the complaint was escalated to a level ii investigation. The device history record was reviewed for non-conformance reports and reworks. There were no ncrs or re-works found that would have caused or contributed to the reported event. Device was not received from customer.
Patient Sequence No: 1, Text Type: N, H10
[39202021]
It was reported after a case, while the customer was venting the acm v6 the exhaust tubing at back of unit came off. The nitrous oxide coming out the nozzle caused a burn on nurse's forearm. The nurse suffered a 2nd degree burn and silvidene was applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2016-00007 |
| MDR Report Key | 5463697 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-02-26 |
| Date of Report | 2016-01-29 |
| Date of Event | 2016-01-29 |
| Date Mfgr Received | 2016-01-29 |
| Date Added to Maude | 2016-02-26 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RANJANA IYER |
| Manufacturer Street | 6217 CENTRE PARK DRIVE |
| Manufacturer City | WEST CHESTER OH 450693886 |
| Manufacturer Country | US |
| Manufacturer Postal | 450693886 |
| Manufacturer Phone | 5137555328 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 6217 CENTE PARK DRIVE |
| Manufacturer City | WEST CHESTER OH 450693886 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 450693886 |
| 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 | 2016-02-26 |
| Model Number | ACM V6 |
| Catalog Number | A000898 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-26 |