MAUDE Adverse Event Report: CORINDUS INC CORPATH GRX SYSTEM; CORPATH GRX EXTENDED REACH ARM

Model Number 303

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  malfunction  

Event Description

Service reports that during connection of the rd cable by the user during setup, a pin of the connector was broken.This resulted in a burnt connector and a damaged pcb.

• Brand Name: CORPATH GRX SYSTEM
• Type of Device: CORPATH GRX EXTENDED REACH ARM
• Manufacturer (Section D): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• MDR Report Key: 12102214
• MDR Text Key: 280521532
• Report Number: 3007822508-2021-00001
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: 00816280023031
• Combination Product (y/n): N
• PMA/PMN Number: K173806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1