MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-03-08 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683-JP manufactured by Atricure, Inc..
[102127378]
(b)(4). The devices were returned for evaluation on 2/28/2018. Each device and associated sterile packaging was visually inspected. The complaint was confirmed for sterility breach that was determined during the incoming inspection process. Further investigation into this device malfunction has been initiated.
Patient Sequence No: 1, Text Type: N, H10
[102127379]
On (b)(6) 2018, a distributor reported that three (3) cryoice cryoablation probes (cryo2) failed incoming inspection because the sterile pack was torn. This was discovered upon receipt by the distributor. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00133 |
| MDR Report Key | 7323205 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-03-08 |
| Date of Report | 2018-03-07 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2018-03-08 |
| 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 | ANUPAM BEDI |
| 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 | 2018-03-08 |
| Returned To Mfg | 2018-02-28 |
| Model Number | CRYO2 |
| Catalog Number | A000683-JP |
| Lot Number | 78810 |
| 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 | 2018-03-08 |