MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-30 for CORPATH GRX SYSTEM 301 manufactured by Corindus, Inc..
[146649763]
The capacitive touch feature is intended to prevent inadvertent movement of the interventional devices from inanimate objects. However no unintended movement of interventional devices was reported.
Patient Sequence No: 1, Text Type: N, H10
[146649764]
It was reported that the green light which indicates that the capacitive touch feature of the device joystick is active remained on even when the user took his hand off of the joystick.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2019-00003 |
| MDR Report Key | 8655685 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-05-08 |
| Device Manufacturer Date | 2018-10-26 |
| Date Added to Maude | 2019-05-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RP |
| 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 | 2019-05-30 |
| Model Number | 301 |
| Catalog Number | 301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORINDUS, INC. |
| Manufacturer Address | 309 WAVERLEY OAKS ROAD SUITE 105 WALTHAM MA 02452 US 02452 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |