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..
[59408502]
After investigation, corindus has repaired this unit during normal service activities.
Patient Sequence No: 1, Text Type: N, H10
[59408503]
The customer reported that the articulated arm was failing to hold position. During investigation, it was found that the pivot 1 joint was loose resulting in a lack of stability for the arm. 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 | 3007822508-2016-00007 |
MDR Report Key | 6076579 |
Date Received | 2016-11-03 |
Date of Report | 2016-11-01 |
Date of Event | 2015-02-11 |
Date Mfgr Received | 2015-03-12 |
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 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 | 2016-11-03 |
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 |