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

Model Number 303

Device Problem Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  malfunction  

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 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
• Type of Device: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• Manufacturer (Section G): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• Manufacturer Contact: robert lavado ; 309 waverley oaks road; suite 105; waltham, MA 02452 ; 5086533335
• MDR Report Key: 9109643
• MDR Text Key: 195583326
• Report Number: 3007822508-2019-00009
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: (01)00816280023031(11)181108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 303
• Device Catalogue Number: 303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1