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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE; ELECTRODES
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COSMAN MEDICAL NITINOL TC ELECTRODE; ELECTRODES Back to Search Results
Model Number TCN-10-3M
Medical Device Problem Codes Break (1069); Material Discolored (1170); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/01/2017
Type of Reportable Event Malfunction
Event or Problem Description
The device analysis performed showed that the epoxy has chip out and brown discoloration.In addition, the electrode failed the temperature test as it reads no temperature.It had a defective thermocouple circuit.The open circuit was measured at the connector.The color of newly cured epoxy is amber, light brown.If the epoxy is subjected to too many autoclave cycles, the epoxy becomes brittle and discolored.
 
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Brand Name
NITINOL TC ELECTRODE
Common Device Name
ELECTRODES
Manufacturer (Section D)
COSMAN MEDICAL
22 terry ave
burlington MA 01803
MDR Report Key6853580
Report Number3006630150-2017-03421
Device Sequence Number649281
Product Code GXI
UDI-Device Identifier00813250017502
UDI-Public00813250017502
Combination Product (Y/N)N
Initial Reporter StateGA
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) 09/01/2017
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 NumberTCN-10-3M
Device Lot Number042216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/01/2017
Initial Report FDA Received Date09/08/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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