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

Model Number	CSK-TC15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model: csk-tc10 lot: k395 description: csk tc electrode, 10cm.
Event or Problem Description
A report was received that one csk-tc15 electrode and one csk-tc10 electrode were broken at the hub.
Additional Manufacturer Narrative
Model: csk-tc15, lot: k514 device analysis on the one returned electrode revealed the electrode shaft was separated from the hub and not returned for analysis.The root cause of the failure is excessive external mechanical force placed upon the shaft which led to the complete separation of the shaft from the hub.Model: csk-tc10, lot: k395 device analysis on the one returned electrode revealed the electrode shaft was separated from the hub and not returned for analysis.The root cause of the failure is excessive external mechanical force placed upon the shaft which led to the complete separation of the shaft from the hub.
Event or Problem Description
A report was received that one csk-tc15 electrode and one csk-tc10 electrode were broken at the hub.

• Brand Name: CSK-TC ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7299900
• Report Number: 3006630150-2018-00854
• Device Sequence Number: 957386
• Product Code: GXI
• UDI-Device Identifier: 00813250010114
• UDI-Public: 00813250010114
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• 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: CSK-TC15
• Device Lot Number: K514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1