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

Model Number	303
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corindus service personnel investigated the problem and found a burnt cable assembly.The customer reported that they had moved and re-installed the robotic drive.It is likely that the lemo connector was damaged during this event which lead to the electrical short.Per the corpath grx system's operator's manual, the user should inspect for worn and damaged cabeling and not use the system if damaged cables are detected.Specifically, the operator's manual states "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
It was reported that the robotic drive did not power on.Upon investigation from the corindus service team, it was noted that the electrical cable was burnt and the pins were missaligned.

• 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: 9109643
• Report Number: 3007822508-2019-00009
• Device Sequence Number: 3242445
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: (01)00816280023031(11)181108
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: No Information
• Device Model Number: 303
• Device Catalogue Number: 303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1