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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMAN MEDICAL CSK ELECTRODE; PROBE, RADIOFREQUENCY LESION
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COSMAN MEDICAL CSK ELECTRODE; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number CSK-TC5
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2018
Event Type  malfunction  
Event Description
The device analysis performed on the electrode (csk-t5, lot m229) revealed that a portion of the shaft of the electrode was broken off due to excessive external mechanical force.The device analysis performed on five electrodes (csk-tc10, all with lot k239) found that the electrodes were completely separated from the hub due to excessive external mechanical force.The device analysis performed on the electrode (csk-10tc, lot k509) revealed that the electrode was completely separated from the hub due to excessive external mechanical force.
 
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Brand Name
CSK ELECTRODE
Type of Device
PROBE, RADIOFREQUENCY LESION
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 Key7474156
MDR Text Key106954952
Report Number3006630150-2018-01506
Device Sequence Number1
Product Code GXI
UDI-Device Identifier00813250010091
UDI-Public00813250010091
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 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberCSK-TC5
Device Lot NumberM229
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2018
Initial Date FDA Received04/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2017
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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