MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-30 for CORPATH GRX SYSTEM 302 manufactured by Corindus, Inc..
[146649725]
Visual inspection during a servicing event showed that electrical shielding from the power cable was damaged. A review of manufacturing and installation records indicated that the system was manufactured and installed per specification. As such, it is likely that the user damaged the cable at some point. No patient or user injury was reported as a result of this malfunction. In addition, the operator's manual for the system warns the user against the use of the system with damaged cabling. Specifically the operator's manual states "operator injury could result from worn or damaged cabling or disassembly of the unit. To avoid exposure to potentially hazardous voltages, do not disassemble the corpath grx system outside of the instructions in this manual. Worn cabling also creates voltage hazards. If you detect worn or damaged cables do not use the system".
Patient Sequence No: 1, Text Type: N, H10
[146649726]
During a service event, it was discovered that the power cable in the extended reach arm was damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2019-00002 |
| MDR Report Key | 8655565 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-05-20 |
| Device Manufacturer Date | 2017-09-19 |
| 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 |
| 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 | 302 |
| Catalog Number | 302 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-05-30 |