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

Model Number	303
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CORPATH GRX EXTENDED REACH ARM
• Manufacturer (Section D): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• MDR Report Key: 12102214
• Report Number: 3007822508-2021-00001
• Device Sequence Number: 19205705
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: 00816280023031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 303
• Device Catalogue Number: 303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1