MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for CORPATH 200 SYSTEM 160-00807 manufactured by Corindus, Inc..
[59458896]
After investigation, corindus has repaired this unit during normal service activities.
Patient Sequence No: 1, Text Type: N, H10
[59458897]
The customer reported that the articulated arm joints were loose and that the arm was moving freely. This issue occured prior to the procedure during setup and therefore did not have any patient involvement. Failure of the arm to hold position has the potential to result in unintended motion of the interventional devices if used on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2016-00002 |
| MDR Report Key | 6076612 |
| Date Received | 2016-11-03 |
| Date of Report | 2016-11-03 |
| Date of Event | 2014-10-10 |
| Date Mfgr Received | 2015-10-22 |
| Date Added to Maude | 2016-11-03 |
| 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 WAVELEY OAKS ROAD SUITE 105 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02452 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CORPATH 200 SYSTEM |
| Generic Name | CORPATH 200 SYSTEM |
| Product Code | DXX |
| Date Received | 2016-11-03 |
| Catalog Number | 160-00807 |
| Operator | PHYSICIAN |
| 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 | 2016-11-03 |