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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
Device Problems Material Discolored (1170); Material Erosion (1214)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2017
Event Type  malfunction  
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 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
Type of Device
ELECTRODES
Manufacturer (Section D)
COSMAN MEDICAL
22 terry ave
burlington MA 01803
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key6788910
MDR Text Key82670739
Report Number3006630150-2017-02839
Device Sequence Number1
Product Code GXI
UDI-Device Identifier00813250013061
UDI-Public00813250013061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberTCN-15
Device Lot Number090613
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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