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

Model Number	302
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection during a servicing event showed that electrical shielding from the power cable was damaged.A review of manufacturing and installation records indicated that the system was manufactured and installed per specification.As such, it is likely that the user damaged the cable at some point.No patient or user injury was reported as a result of this malfunction.In addition, the operator's manual for the system warns the user against the use of the system with damaged cabling.Specifically the operator's manual states "operator injury could result from worn or damaged cabling or disassembly of the unit.To avoid exposure to potentially hazardous voltages, do not disassemble the corpath grx system outside of the instructions in this manual.Worn cabling also creates voltage hazards.If you detect worn or damaged cables do not use the system".
Event or Problem Description
During a service event, it was discovered that the power cable in the extended reach arm was damaged.

• 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: 8655565
• Report Number: 3007822508-2019-00002
• Device Sequence Number: 11334223
• Product Code: DXX
• UDI-Device Identifier: 00816280023024
• UDI-Public: (01)00816280023024(11)170919
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K180517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare 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: 302
• Device Catalogue Number: 302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2019
• 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