MAUDE Adverse Event Report: CORINDUS, INC. CORPATH GRX SYSTEM

Model Number	301
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The capacitive touch feature is intended to prevent inadvertent movement of the interventional devices from inanimate objects.However no unintended movement of interventional devices was reported.
Event or Problem Description
It was reported that the green light which indicates that the capacitive touch feature of the device joystick is active remained on even when the user took his hand off of the joystick.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• MDR Report Key: 8655685
• Report Number: 3007822508-2019-00003
• Device Sequence Number: 11334190
• Product Code: DXX
• UDI-Device Identifier: 00816280023017
• UDI-Public: (01)00816280023017(11)181026
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 301
• Device Catalogue Number: 301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1