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

Model Number	312
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corindus service personnel investigated the problem and found that a burnt cable assembly and a defective arm controller board.Both parts were replaced and the system is functioning normally.A source of the failure could not be confirmed as the user had discarded the connection cable prior to the service personnel's arrival.However, it is likely that the lemo connector became loose and lead to a damaged cable and shorted arm board.
Event or Problem Description
During preparation for a hospital training event, it was observed that the robotic drive was functioning as if there was a loose connection and unexpectedly shut down.Upon investigation it was observed that a burnt port was present an electrical connector of the extended reach arm.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX DEVICE
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• MDR Report Key: 8961205
• Report Number: 3007822508-2019-00007
• Device Sequence Number: 2563371
• Product Code: DXX
• UDI-Device Identifier: 00816280023123
• UDI-Public: (01)00816280023123(11)190422
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K180517
• 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): 09/04/2019

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: 312
• Device Catalogue Number: 312
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1