MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-24 for CORPATH GRX SYSTEM 302 manufactured by Corindus, Inc..
[109505503]
A corindus service engineer evaluated the extended reach arm at the customers site. The engineer's investigation was inconclusive and could not replicate the error. The extended reach arm was found to be functioning as intended. In addition, the user did not report any unintentional movement of system due to the unlocked arm.
Patient Sequence No: 1, Text Type: N, H10
[109505504]
The customer reported that during the pci procedure the corpath grx system provided an error code stating that the extended reach arm had become unexpectedly unlocked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00002 |
| MDR Report Key | 7540356 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2017-06-07 |
| Date Added to Maude | 2018-05-24 |
| 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. ROBERT LAVADO |
| Manufacturer Street | 309 WAVERLEY OAKS ROAD SUITE 105 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal | 02452 |
| Manufacturer Phone | 5086533335 |
| Manufacturer G1 | CORINDUS, INC. |
| Manufacturer Street | 309 WAVERLEY OAKS ROAD SUITE 105 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02452 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORPATH GRX SYSTEM |
| Generic Name | CORPATH GRX SYSTEM |
| Product Code | DXX |
| Date Received | 2018-05-24 |
| Model Number | 302 |
| Catalog Number | 302 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORINDUS, INC. |
| Manufacturer Address | 309 WAVERLEY OAK ROAD SUITE 105 WALTHAM MA 02452 US 02452 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-24 |