MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-04 for CORPATH 200 SYSTEM 160-00807 manufactured by Corindus, Inc..
[59504400]
After investigation, corindus has repaired this unit during normal service activities.
Patient Sequence No: 1, Text Type: N, H10
[59504401]
During service, it was determined that the articulated arm pivot 1 and pivot 2 joints were loose and over-rotating. No patient involvement was reported. 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 | 3007822508-2016-00020 |
| MDR Report Key | 6079561 |
| Date Received | 2016-11-04 |
| Date of Report | 2016-11-04 |
| Date of Event | 2014-10-06 |
| Date Mfgr Received | 2014-10-06 |
| Date Added to Maude | 2016-11-04 |
| 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 |
| 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 | 2016-11-04 |
| 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 | 2016-11-04 |