MAUDE Adverse Event Report: CORINDUS INC CORPATH GRX ROBOTIC DRIVE; CORPATH GRX ROBOTIC DRIVE POWER CORD/CABLE

Model Number	303
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service technician visit was completed and it was reported that the staff bent a pin on the 24v power plug when trying to plug it.The operator noticed the bent bin on the 24v power input connector and tried to straighten it (while still powered on) - which caused the pin to short causing electric sparks.The issue occurred during setup and hence there was no patient involvement.No patient or operator injury was reported due to this malfunction.In addition, the operators manual/instructions for use for the grx system includes warnings about cable damage - specifically "warning: electrical shock hazard - operator injury could result from worn cabling or disassembly of the unit.To avoid exposure to potentially hazardous voltages, do not disassemble the corpath grx system outside of the instructions in this manual.Worn cabling also creates voltage hazards.If you detect any worn or damaged cables, do not use the system.".
Event or Problem Description
It was reported that - "system error when trying to power up.Reports of electrical sparks when connecting, error code 1001".
Additional Manufacturer Narrative
Follow up report/ 9/18/2024: additional information: the device was not returned for evaluation as of this report date.The system was being used as a demo system as part of the investigation study, the study has ended and the device is currently not in use and will no longer be used at the site.However additional information was received from customer service.The customer service engineer (cse) analysis concluded that the customer bent a pin on the plug while trying to force it on with the incorrect orientation, they noticed the bent pin and used a metal object to straighten it with the power to the supply still on so they shorted the pin against the plug outer casing ground causing the sparks.Risk management file was reviewed.Review of the product dfmea showed that the failure mode has been identified and properly mitigated.Further, review of the product instructions for use for the grx system showed the inclusion of warnings about cable damage - specifically "warning: electrical shock hazard - operator injury could result from worn cabling or disassembly of the unit.To avoid exposure to potentially hazardous voltages, do not disassemble the corpath grx system outside of the instructions in this manual.Worn cabling also creates voltage hazards.If you detect any worn or damaged cables, do not use the system.Contact corindus technical support for assistance at (b)(6)".
Event or Problem Description
It was reported that - "system error when trying to power up.Reports of electrical sparks when connecting, error code 1001.".

• Brand Name: CORPATH GRX ROBOTIC DRIVE
• Common Device Name: CORPATH GRX ROBOTIC DRIVE POWER CORD/CABLE
• Manufacturer (Section D): CORINDUS INC; 275 grove st; suite 1-110; newton MA 02466
• Manufacturer (Section G): CORINDUS INC; 275 grove street; suite 1-110; newton MA 02466
• Manufacturer Contact: manjusha bharadwaj ; 275 grove street; suite 1-110; newton, MA 02466
• MDR Report Key: 20176561
• Report Number: 3022099867-2024-00001
• Device Sequence Number: 8577875
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: 00816280023031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown