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

Model Number 309

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2020

Event Type  malfunction  

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 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
• Type of Device: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham, ma
• Manufacturer (Section G): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham, ma
• Manufacturer Contact: robert lavado ; 309 waverley oaks road; suite 105; waltham, ma ; 6533335211
• MDR Report Key: 10062272
• MDR Text Key: 224279357
• Report Number: 3007822508-2020-00002
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023093
• UDI-Public: (01)00816280023093(10)71L2019(17)240725
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309
• Device Catalogue Number: 309
• Device Lot Number: 71L2019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1