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

Device Problem Power Problem (3010)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient or user injury reported.Based on the description of events the substance that leaked from the iv bag was electrolytic and was repeatedly contacting the power input.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.

Event Description

The power supply no longer functioned after an iv bag leaked fluid onto it.

• Brand Name: CORPATH GRX
• Type of Device: CORPATH GRX SYSTEM POWER CORD
• Manufacturer (Section D): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• Manufacturer (Section G): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• Manufacturer Contact: manjusha bharadwaj ; 309 waverly oaks road; waltham, MA 02452
• MDR Report Key: 12860977
• MDR Text Key: 287014867
• Report Number: 3007822508-2021-00005
• Device Sequence Number: 1
• Product Code: DXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other