MAUDE Adverse Event Report: COSMAN MEDICAL TC ELECTRODE; PROBE, RADIOFREQUENCY LESION

Model Number	TCN-10
Medical Device Problem Codes	Material Discolored (1170); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: na /additional suspect medical device components involved/ model #: csk-tc10/ lot #: k510/ description: csk tc electrode, 10cm total quantity: 1 model #: csk-tc10 lot #: l467 description: csk tc electrode, 10cm total quantity: 1 model #: tcn-10 lot #: 011617 description: nitinol tc electrode, 100 mm total quantity: 4.
Event or Problem Description
Device evaluation was performed on the returned products.Csk-tc10 electrodes with lot numbers k510 and l467 was found to have the hub completely separated from the shaft due to excessive mechanical force.Tcn-10 electrodes with lot # 011617 (total quantity 4) had revealed there was discoloration (brown/amber) in the epoxy with chip outs.The discolored epoxy of all four electrodes is unrelated to the reported complaint and is due to external mechanical force and thermal stress associated with multiple autoclave cycles.Tcn-10 electrode with lot # 111516 was found to have discolored epoxy due to external mechanical force and thermal stress associated with multiple autoclave cycles.

• Brand Name: TC ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7440994
• Report Number: 3006630150-2018-01400
• Device Sequence Number: 19105717
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K060799
• 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): 04/18/2018

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: 111516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1