MAUDE Adverse Event Report: COSMAN MEDICAL CSK-TC ELECTRODE; ELECTRODES

Model Number CSK-TC10-3M

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved: model #: csk-tc10-3m lot #: 041617 description: csk 100 mm tc electrode with 3m cable.

Event Description

A report was received that a used electrode was found to have a rusty wire.

Manufacturer Narrative

Device evaluation performed on electrode lot# 040612 showed that the electrode shaft was broken off at the hub.Device evaluation performed on electrode lot# 041617 showed the thermocouple has migrated from tip to a different position on the shaft.The electrode shaft was bent, due to external mechanical force.

Event Description

A report was received that a used electrode was found to have a rusty wire.

• Brand Name: CSK-TC ELECTRODE
• Type of Device: ELECTRODES
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6745790
• MDR Text Key: 81115253
• Report Number: 3006630150-2017-02656
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250011524
• UDI-Public: (01)00813250011524(11)120406(10)120406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CSK-TC10-3M
• Device Lot Number: 040612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1