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

Model Number	CSK-TC15
Medical Device Problem Code	Material Separation (1562)
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
Additional suspect medical device component involved: model: csk-tc15 lot: m065 description: csk tc electrode, 15 cm.
Event or Problem Description
A report was received that an electrode had a wire come out.
Additional Manufacturer Narrative
Csk-tc15/lot l889: the complaint was confirmed.A visual inspection of both electrodes revealed that the shafts were bent due to external mechanical force.Both electrodes would also not register temperature during the functional test.X-ray inspection of the electrodes revealed that fractured wires in the shafts near the tips were causing an open thermocouple circuit.Csk-tc15/lot m678: the complaint was not confirmed.The electrode passed a visual inspection.However, the electrode would not register temperature during the functional test.X-ray inspection revealed that a fractured wire in the hub was causing an open thermocouple circuit.Csk-tc15/lot m039: the complaint was confirmed.A visual inspection of the electrode revealed that the shaft was bent.However, the electrode passed the functional test.
Event or Problem Description
A report was received that an electrode had a wire come out.
Additional Manufacturer Narrative
Additional suspect medical device component involved: model: csk-tc15, lot: l889; description: csk tc electrode, 15 cm, total quantities: 2, model: csk-tc15, lot: m678; description: csk tc electrode, 15 cm, total quantities: 1, model: csk-tc15, lot: m039; description: csk tc electrode, 15 cm, total quantities: 1.
Event or Problem Description
A report was received that an electrode had a wire come out.

• 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: 7299763
• Report Number: 3006630150-2018-00815
• Device Sequence Number: 1067028
• Product Code: GXI
• UDI-Device Identifier: 00813250010114
• UDI-Public: 00813250010114
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2018

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: L889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 05/29/2018; 07/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 06/05/2018; 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1