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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)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/24/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Expiration date: na additional suspect medical device components involved: model #: tcn-10-3m lot #: 030316 description: nitinol tc electrode, 100 mm, with 3m cable total quantity: 3.
 
Event or Problem Description
Device evaluation performed on the returned electrodes found that the epoxy had a chip out and was also discolored.The color of newly cured epoxy is amber, light brown.If the epoxy is subjected to too many autoclave cycles it 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 Key6864449
Report Number3006630150-2017-03335
Device Sequence Number10927672
Product Code GXI
UDI-Device Identifier00813250017502
UDI-Public00813250017502
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K050084
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/24/2017
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 Number030316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/24/2017
Initial Report FDA Received Date09/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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