MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE

Model Number	TCN-5-3M
Medical Device Problem Codes	Break (1069); Material Discolored (1170)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that an electrode shaft is broken from the hub.
Additional Manufacturer Narrative
Tcn-5-3m, lot 061316: the complaint the tcn electrode had a broken shaft was confirmed.Root cause is excessive mechanical force impressed upon the shaft led to the complete fracture of the shaft from the hub.Visual inspection also found that the epoxy exhibits a chip out and discoloration.The color of newly cured epoxy is amber, light brown.If the epoxy is subjected to too many autoclave cycles it becomes brittle and discolored.
Event or Problem Description
A report was received that an electrode shaft is broken from the hub.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6788585
• Report Number: 3006630150-2017-02808
• Device Sequence Number: 16536210
• Product Code: GXI
• UDI-Device Identifier: 00813250014358
• UDI-Public: 00813250014358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: Physician
• Device Model Number: TCN-5-3M
• Device Lot Number: 061316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1