MAUDE Adverse Event Report: COSMAN MEDICAL CSK 10CM TC ELECTRODE WITH 3M CABLE; PROBE, RADIOFREQUENCY LESION

Model Number	CSK-TC15-3M
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	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A total of two electrodes were returned: model: csk-tc15-3m serial/lot: l741 description: csk 15cm tc electrode with 3m cable quantity: 1 model: tcn-15-3m serial/lot: 21816 description: nitinol tc electrode 15cm 3m cable quantity: 1.
Event or Problem Description
Device analysis on the returned electrode (l741) revealed that the shaft of the 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.In addition a second electrode (21816) was analyzed and a visual inspection revealed a 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, the epoxy becomes brittle and discolored.
Additional Manufacturer Narrative
Correction to initial mdr in fields.
Event or Problem Description
Device analysis on the returned electrode (l741) revealed that the shaft of the 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.In addition a second electrode ((b)(4)) was analyzed and a visual inspection revealed a 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, the epoxy becomes brittle and discolored.

• Brand Name: CSK 10CM TC ELECTRODE WITH 3M CABLE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7744571
• Report Number: 3006630150-2018-02305
• Device Sequence Number: 1588497
• Product Code: GXI
• UDI-Device Identifier: 00813250011548
• UDI-Public: 00813250011548
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: CSK-TC15-3M
• Device Lot Number: L741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1