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

Model Number 303

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Visual inspection during a servicing event showed that electrical shielding from some wires were damaged.A review of manufacturing and installation records indicated that the system was manufactured and installed per specification.As such, it is likely that the user damaged the cable at some point.No patient or user injury was reported as a result of this malfunction.In addition, the operator's manual for the system warns the user against the use of the system with damaged cabling.Specifically the operator's manual states "operator injury could result from worn cabling or disassembly of the unit.To avoid exposure to potentially hazardous voltages, do not disassemble the corpath grx system outside of the instructions in this manual.Word cabling also creates voltage hazards.If you detect any worn or damaged cables, do not use the system".

Event Description

During a service event, it was discovered that the electrical cables of the robotic drive and extended reach arm were damaged.

• 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 ; 5086533355
• MDR Report Key: 8522776
• MDR Text Key: 146649929
• Report Number: 3007822508-2019-00001
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: (01)00816280023031(11)170620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 303
• Device Catalogue Number: 303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1