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

Model Number	303
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection by a photo provided to corindus shows that electrical shielding from a wire was missing, likely causing a short circuit when attempting to reconnect the robotic drive to the extended reach arm.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 leading to the short circuit.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 use of the system with damaged cabling.Specifically the operator's manual states "operator injury could result from worn 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 any worn or damaged cables, do not use the system.".
Event or Problem Description
When attempting to connect the cable between the robotic drive and extended reach arm, sparks were seen.

• 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: 7616354
• Report Number: 3007822508-2018-00003
• Device Sequence Number: 2074194
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: (01)00816280023031(11)170220
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: Physician
• Device Model Number: 303
• Device Catalogue Number: 303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1