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 2018-06-19 for CORPATH GRX SYSTEM 303 manufactured by Corindus, Inc..
[112346072]
Visual inspection by a photo provided to corindus shows that electrical shielding from a wire was missing, likely causing a short circuit when attempting to reconnect the robotic drive to the extended reach arm. 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 leading to the short circuit. 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 use of the system with damaged cabling. Specifically the operator's manual states "operator injury could result from worn 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 any worn or damaged cables, do not use the system. "
Patient Sequence No: 1, Text Type: N, H10
[112346073]
When attempting to connect the cable between the robotic drive and extended reach arm, sparks were seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00003 |
| MDR Report Key | 7616354 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-19 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-05-25 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2017-02-20 |
| Date Added to Maude | 2018-06-19 |
| 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 | 2018-06-19 |
| Returned To Mfg | 2018-06-12 |
| Model Number | 303 |
| Catalog Number | 303 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2018-06-19 |