MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-09 for CORPATH CORPATH 200 CONTROL 160-00043 manufactured by Corindus, Inc..
[51496348]
Patient Sequence No: 1, Text Type: N, H10
[51496349]
There was a communicating error on the corindus robotics device. The cath lab staff attempted to connect the robotic arm to the corindus machine. The machine started the standard "self-service" test and a communication error was received. The system was rebooted and the same error message occurred. This occurred several times. Several other troubleshooting techniques were tried with no success. The cable was replaced and the same message was still occurring. The rep was contacted, but was not available. The robotic system was then discontinued and the procedure was completed with no harm to the patient. After the procedure was complete and the patient was discharged from the cath lab a system reboot was performed again. This time it was successful and there were no further problems with the corindus machine. The rep called back and came to the cath lab to check the system, but could not find any errors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5856429 |
| MDR Report Key | 5856429 |
| Date Received | 2016-08-09 |
| Date of Report | 2016-06-20 |
| Date of Event | 2016-05-19 |
| Report Date | 2016-06-20 |
| Date Reported to FDA | 2016-06-20 |
| Date Reported to Mfgr | 2016-06-20 |
| Date Added to Maude | 2016-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORPATH |
| Generic Name | SYSTEM, CATHETER CONTROL, STEERABLE |
| Product Code | DXX |
| Date Received | 2016-08-09 |
| Model Number | CORPATH 200 CONTROL |
| Catalog Number | 160-00043 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORINDUS, INC. |
| Manufacturer Address | 309 WAVERLEY OAKS RD STE. 105 WALTHAM, MA 02452 US 02452 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-09 |