MAUDE Adverse Event Report: CORINDUS, INC. CORPATH GRX SYSTEM - ROBOTIC DRIVE AND ARM DRAPE

Model Number	309
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tear in the drape for the robotic drive and arm was found during setup of the system.Error was found prior to use of the device.The drape provides an extension of the sterile field during the procedure, and as such a tear could have caused a breach in the sterile field.However the arm is outside of the critical area and as such the risk to the patient is minor.Lot history records were reviewed and no manufacturing issues were identified.Issue will continue to be monitored for trending.
Event or Problem Description
Staff found a tear in the robotic arm and drive drape when setting up for a corpath grx procedure.

• Brand Name: CORPATH GRX SYSTEM - ROBOTIC DRIVE AND ARM DRAPE
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham, ma
• MDR Report Key: 10062272
• Report Number: 3007822508-2020-00002
• Device Sequence Number: 3514175
• Product Code: DXX
• UDI-Device Identifier: 00816280023093
• UDI-Public: (01)00816280023093(10)71L2019(17)240725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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: Health Professional
• Device Expiration Date: 07/25/2024
• Device Model Number: 309
• Device Catalogue Number: 309
• Device Lot Number: 71L2019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1