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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 08/21/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Na additional suspect medical device components involved: model #: tcn-10-3m lot #: 030515 description: nitinol tc electrode, 100 mm, with 3m cable.
 
Event or Problem Description
Device evaluation for the returned electrodes revealed that the epoxy was discolored and had a chip out.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 Key6819185
Report Number3006630150-2017-03201
Device Sequence Number16177696
Product Code GXI
UDI-Device Identifier00813250017502
UDI-Public00813250017502
Combination Product (Y/N)N
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 08/21/2017
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 Number060215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/21/2017
Initial Report FDA Received Date08/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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