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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMAN MEDICAL CSK-TC ELECTRODE; PROBE, RADIOFREQUENCY LESION
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COSMAN MEDICAL CSK-TC ELECTRODE; PROBE, RADIOFREQUENCY LESION Back to Search Results
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 11/01/2017
Type of Reportable Event Malfunction
Event or Problem Description
Device analysis of the returned electrode revealed that the shaft was separated from the hub and not returned for analysis.Root cause of the failure is excessive external mechanical force placed upon the shaft which led to the complete separation of the shaft from the hub.
 
Additional Manufacturer Narrative
Correction to initial mdr in field.It should have been (b)(6) 2017.
 
Event or Problem Description
Device analysis of the returned electrode revealed that the shaft was separated from the hub and not returned for analysis.Root cause of the failure is excessive external mechanical force placed upon the shaft which led to the complete separation of the shaft from the hub.
 
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Brand Name
CSK-TC ELECTRODE
Common Device Name
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
COSMAN MEDICAL
22 terry ave
burlington MA 01803
MDR Report Key7028037
Report Number3006630150-2017-04724
Device Sequence Number1851422
Product Code GXI
UDI-Device Identifier00813250010114
UDI-Public00813250010114
Combination Product (Y/N)N
Initial Reporter StateNV
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,Followup
Report Date (Section B) 11/16/2017
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 NumberCSK-TC15
Device Lot NumberL470
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2017
Initial Date Received by Manufacturer 11/01/2017
Supplement Date Received by Manufacturer11/01/2017
Initial Report FDA Received Date11/14/2017
Supplement Report FDA Received Date11/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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