MAUDE Adverse Event Report: CORINDUS, INC CORPATH GRX SYSTEM

Model Number 303

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 06/12/2020

Event Type  malfunction  

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 Description

Suspect wiring issue as robotic drive connector has a burn mark.

• Brand Name: CORPATH GRX SYSTEM
• Type of Device: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC; 309 waverly oaks road; waltham, ma
• Manufacturer (Section G): CORINDUS,INC; 309 waverly oaks road; suite 105; waltham, ma
• Manufacturer Contact: manjusha bharadwaj ; 309 waverly oaks road; waltham, ma
• MDR Report Key: 10254445
• MDR Text Key: 198859075
• Report Number: 3007822508-2020-00003
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: (01)00816280023031(11)180828
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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?: Yes
• Date Manufacturer Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2018
• 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