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 2018-07-24 for CORPATH GRX SYSTEM 303 manufactured by Corindus, Inc..
[114946653]
A corindus service engineer inspected the touchscreen and determined that it contained particles from an ammonium salt based cleaning solution. The corpath grx operator's manual states that "isopropyl alcohol (ipa) based disinfectants, germicides such as spor-klenz, or 10% to 20% bleach solutions" are recommended for cleaning. The use of an alternate cleaning solution may have led to the failure of the robotic drive touchscreen. The service engineer replaced the touchscreen and system is now functioning as intended.
Patient Sequence No: 1, Text Type: N, H10
[114946654]
The robotic drive touchscreen became unresponsive when the technician selected "load/exchange device" to remove the guidewire. The system was rebooted but the "continue case" button could not be selected due to the unresponsive touchscreen. The emergency release button on the cassette had to be pressed to disassemble the cassette and remove the interventional devices from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00005 |
| MDR Report Key | 7713953 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-07-09 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2018-07-24 |
| 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 | 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 | 2018-07-24 |
| Model Number | 303 |
| Catalog Number | 303 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-24 |