MAUDE Adverse Event Report: CORINDUS INC CORPATH GRX; CORPATH GRX SYSTEM POWER CORD

Model Number 11586090

Device Problems Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

The event did not occur while in procedure or on patient.There was no patient involvement or injury.The root cause for the damaged power supply can be attributed to water (contrast and saline) that was spilt by the customer.When an electrolytic solution is present on an area of the power input a reaction can occur that results in the issue that was reported.The power supply contained the reaction as designed by preventing damage to the robot or the user or patient experiencing harm.The device functioned as intended.

Event Description

"customer has spilled water, contrast and saline on the power supply.Power supply led was not glowing and no output".

• Brand Name: CORPATH GRX
• Type of Device: CORPATH GRX SYSTEM POWER CORD
• Manufacturer (Section D): CORINDUS INC; 275 grove street; 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: 15699933
• MDR Text Key: 306989135
• Report Number: 3007822508-2022-00001
• Device Sequence Number: 1
• Product Code: DXX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K173806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11586090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1