MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-11-09 for CRYOICE CRYO-ABLATION PROBE A000683-JP manufactured by Atricure, Inc..
[128606318]
Case-(b)(4): the device was returned for evaluation, device lot number 84256. Complaint is confirmed for torn mylar, source of the tear is a result of packaging design and customer handling of product. There was no patient involvement. Torn mylar was determined during incoming inspection.
Patient Sequence No: 1, Text Type: N, H10
[128606319]
It was reported on 10/17/2018 that the distributor received a cryo2 device that failed incoming inspection for the sterile package being torn. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00217 |
| MDR Report Key | 8056965 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-06-12 |
| Date Added to Maude | 2018-11-09 |
| 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 EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137554563 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOICE CRYO-ABLATION PROBE |
| Generic Name | CRYOICE CRYO-ABLATION PROBE |
| Product Code | GXH |
| Date Received | 2018-11-09 |
| Returned To Mfg | 2018-11-06 |
| Model Number | CRYOICE CRYO-ABLATION PROBE |
| Catalog Number | A000683-JP |
| Lot Number | 84256 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-09 |