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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMAN MEDICAL CSK ELECTRODE; PROBE, RADIOFREQUENCY LESION
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COSMAN MEDICAL CSK ELECTRODE; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number CSK-TC5
Medical Device Problem Codes Break (1069); Material Separation (1562)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/05/2018
Type of Reportable Event Malfunction
Event or Problem Description
The device analysis performed on the electrode (csk-t5, lot m229) revealed that a portion of the shaft of the electrode was broken off due to excessive external mechanical force.The device analysis performed on five electrodes (csk-tc10, all with lot k239) found that the electrodes were completely separated from the hub due to excessive external mechanical force.The device analysis performed on the electrode (csk-10tc, lot k509) revealed that the electrode was completely separated from the hub due to excessive external mechanical force.
 
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Brand Name
CSK ELECTRODE
Common Device Name
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
COSMAN MEDICAL
22 terry ave
burlington MA 01803
MDR Report Key7474156
Report Number3006630150-2018-01506
Device Sequence Number19140779
Product Code GXI
UDI-Device Identifier00813250010091
UDI-Public00813250010091
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K050084
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
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? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Model NumberCSK-TC5
Device Lot NumberM229
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2018
Initial Report FDA Received Date04/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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