MAUDE Adverse Event Report: COSMAN MEDICAL CSK-TC ELECTRODE

Model Number CSK-TC10

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2017

Event Type  malfunction  

Event Description

Device analysis performed on the returned electrode found traces of potting epoxy on the hub.The epoxy leaked through the shaft opening in its liquid state during the manufacturing process, and was not removed after curing.

• Brand Name: CSK-TC ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6904648
• MDR Text Key: 87783814
• Report Number: 3006630150-2017-03832
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250010107
• UDI-Public: 00813250010107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CSK-TC10
• Device Lot Number: 031317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1