MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE 10CM; PROBE, RADIOFREQUENCY LESION

Model Number	TCN-10
Medical Device Problem Codes	Material Discolored (1170); Material Separation (1562); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quave clinic 701 golf view drive medford or 96080 united states additional suspect medical device components involved in the event: model: tcn-10 serial/lot: (b)(4) description: nitinol tc electrode 10cm quantity:1 model: tcn-10 serial/lot: (b)(4) description: nitinol tc electrode 10cm 3m cable quantity:1 model: tcn-15 serial/lot: (b)(4) description: nitinol tc electrode 15cm quantity:1.
Event or Problem Description
Device evaluation performed on the returned electrodes tcn-10 (lot 013017) and tcn-10 (lot 110916) showed that the epoxy was discolored 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 due to external mechanical force and thermal stress associated with multiple autoclave cycles.Evaluation of tcn-15 (lot 052715) revealed a chip out.This failure mechanism is due to external mechanical force.

• Brand Name: NITINOL TC ELECTRODE 10CM
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7826838
• Report Number: 3006630150-2018-02335
• Device Sequence Number: 1287584
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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: Health Professional
• Device Model Number: TCN-10
• Device Lot Number: 013017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1