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

Model Number	302
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service personnel noticed that the cable was damaged during service, the cable was immediately fixed.The system was never used for a patient case until the damage was corrected.There was no other user/staff injury or adverse event reported.
Event or Problem Description
Service personnel noted that cable from era(extended reach arm) to robotic drive damaged, during service.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX EXTENDED REACH ARM
• Manufacturer (Section D): CORINDUS INC; 309 waveryly oaks road; waltham MA 02452
• MDR Report Key: 10686330
• Report Number: 3007822508-2020-00004
• Device Sequence Number: 17008482
• Product Code: DXX
• UDI-Device Identifier: 00816280023024
• UDI-Public: (01)00816280023024(11)171206
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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 Model Number: 302
• Device Catalogue Number: 302
• Device Lot Number: 202031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1