MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL 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	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: na.A total of (5) electrodes were analyzed: tcn-10, lot 011116, quantity (1), nitinol tc electrode, 100 mm the device analysis performed on the (1) 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.This failure mechanism is unrelated to the reported complaint and is due to external mechanical force and thermal stress associated with multiple autoclave cycles.Tcn-15 lot 051016, quantity (3) nitinol tc electrode, 150 mm the device analysis performed on the (3) electrodes 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.This failure mechanism is unrelated to the reported complaint and is due to external mechanical force and thermal stress associated with multiple autoclave cycles.Csk-tc10, lot n184, quantity (1) csk tc electrode, 10cm the device analysis performed on the (1) electrode was found to be completely separated from the hub due to excessive external mechanical force.The shaft was not returned for analysis.The functional test could not be performed due to the separated shaft.
Event or Problem Description
The device analysis performed on the five electrodes revealed that four of them had 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.This failure mechanism is unrelated to the reported complaint and is due to external mechanical force and thermal stress associated with multiple autoclave cycles.The device analysis performed on the fifth electrode was found to be completely separated from the hub due to excessive external mechanical force.The shaft was not returned for analysis.The functional test could not be performed due to the separated shaft.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7531900
• Report Number: 3006630150-2018-01781
• Device Sequence Number: 156962
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K50084
• 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): 05/21/2018

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: 011116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1