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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-15
Medical Device Problem Codes Material Discolored (1170); Material Erosion (1214)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/05/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Expiration date: na.Additional suspect medical device components involved: model: tcn-15 lot: 090613 description: nitinol tc electrode, 150 mm quantity: 3 model: tcn-15 lot: 091614 description: nitinol tc electrode, 150 mm quantity: 1.
 
Event or Problem Description
Device analysis performed on all the returned electrodes showed that the epoxy was chipped out and discolored due to thermal stress associated with autoclave cycles.
 
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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 Key6788910
Report Number3006630150-2017-02839
Device Sequence Number138553
Product Code GXI
UDI-Device Identifier00813250013061
UDI-Public00813250013061
Combination Product (Y/N)N
Initial Reporter StateTX
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) 05/05/2017
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-15
Device Lot Number090613
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/24/2017
Initial Report FDA Received Date08/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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