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	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: n/a.Additional suspect medical device components involved in the event.Model:csk-tc15 lot: l892 description: csk tc electrode, 15 cm total quantity: two - both lot l892.
Event or Problem Description
A report was received that the electrodes were broken at the hub.
Additional Manufacturer Narrative
Csk-tc15 lot l892 ¿ quantity three: the shafts of all three electrodes were found to be completely separated from the hubs due to excessive external mechanical force.The shafts were not returned for analysis.The functional test could not be performed due to the separated shafts.Additional suspect medical device components involved in the event: model: csk-tc10 description: csk tc electrode, 10cm lot m032 - quantity eight lot k397 ¿ quantity one lot l466 ¿ quantity one lot m406 ¿ quantity one the shafts of these eleven electrodes were found to be completely separated from the hub due to excessive external mechanical force.The shafts were not returned for analysis.The functional test could not be performed due to the separated shafts.
Event or Problem Description
A report was received that the electrodes 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: 7356113
• Report Number: 3006630150-2018-01114
• Device Sequence Number: 13959147
• 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): 05/15/2018

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: L892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/21/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1