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

Model Number 312

Device Problem Electrical Shorting (2926)

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

Event Date 07/29/2019

Event Type  malfunction  

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 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
• Type of Device: CORPATH GRX DEVICE
• 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: 8961205
• MDR Text Key: 194633923
• Report Number: 3007822508-2019-00007
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023123
• UDI-Public: (01)00816280023123(11)190422
• 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: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 312
• Device Catalogue Number: 312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• 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