MAUDE Adverse Event Report: CORINDUS, INC CORPATH GRX SYSTEM

Model Number	303
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corindus service personnel investigated the problem and found a burnt cable indicating a possible electrical short.No patient involvement.There was no patient or operator injury due to the issue.The initial investigation has not been able to duplicate any failures.The issue will be monitored and trended in future complaints.
Event or Problem Description
Suspect wiring issue as robotic drive connector has a burn mark.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC; 309 waverly oaks road; waltham, ma
• MDR Report Key: 10254445
• Report Number: 3007822508-2020-00003
• Device Sequence Number: 14104251
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: (01)00816280023031(11)180828
• Combination Product (Y/N): N
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1