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	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: na.Additional suspect medical device component involved in the event: model: csk-tc10 lot: l884 description: csk tc electrode, 10cm.
Event or Problem Description
A report was received that the wire electrode was broken off from the hub of the csk-tc15, and that the plastic covering at the hub was cracked on the csk-tc10 electrode.
Additional Manufacturer Narrative
Correction to fu 1 report in field.It should have been (b)(6) 2018.
Event or Problem Description
A report was received that the wire electrode was broken off from the hub of the csk-tc15, and that the plastic covering at the hub was cracked on the csk-tc10 electrode.
Additional Manufacturer Narrative
The device analysis performed on csk-tc15, s/n (b)(4) revealed that the shaft of the electrode was found to be completely separated from the hub due to excessive external mechanical force.The functional test could not be performed due to the separated shaft.The complaint of the plastic covering at the hub being cracked on the csk-tc10 s/n (b)(4) was confirmed.Visual inspection found that the blue insulation that covers the hub of the electrode was damaged.However, the electrode passed the functional test.
Event or Problem Description
A report was received that the wire electrode was broken off from the hub of the csk-tc15, and that the plastic covering at the hub was cracked on the csk-tc10 electrode.

• 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: 7283803
• Report Number: 3006630150-2018-00782
• Device Sequence Number: 1044082
• 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,Followup
• Report Date (Section B): 04/30/2018

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: L221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 04/04/2018; 04/04/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/30/2018; 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1