MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE; ELECTRODES

Model Number	TCN-10
Medical Device Problem Codes	Break (1069); Material Discolored (1170); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The device analysis performed on the returned electrode revealed discolored epoxy and a chip out.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.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: ELECTRODES
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7118054
• Report Number: 3006630150-2017-05266
• Device Sequence Number: 16517916
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/14/2017

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-10
• Device Lot Number: 110416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1