MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-01-22 for UNIVERSAL STABILIZER ARM, HERCULES 3 001-401-161 manufactured by Atricure, Inc..
[135371504]
Case-(b)(4) the device was returned and an evaluation for the hercules 3? Lot number 72808 was performed. The complaint was confirmed upon receipt of the device and with photographic evidence by the distributor. One of the two lock plates was missing and was not returned with the product. As a result, the retractor mount locking mechanism was not functioning as intended. There was no patient involvement for this complaint.
Patient Sequence No: 1, Text Type: N, H10
[135371505]
It was reported that on (b)(6) 2018 while the facility was doing a maintenance inspection, the locking plate of the hercules 3 arm was found cracked. The hospital states device was used for only 10 months. There was no patient involvement associated with this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00006 |
| MDR Report Key | 8267414 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2019-01-22 |
| 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 | UNIVERSAL STABILIZER ARM, HERCULES 3 |
| Generic Name | UNIVERSAL STABILIZER ARM, HERCULES 3 |
| Product Code | DWS |
| Date Received | 2019-01-22 |
| Returned To Mfg | 2019-01-11 |
| Model Number | 001-401-161 |
| Catalog Number | 001-401-161 |
| Lot Number | 72808 |
| 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 | 2019-01-22 |