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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION
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BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number CSK-TC15
Device Problem Insufficient Heating (1287)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2018
Event Type  malfunction  
Event Description
A report was received that the returned electrode revealed that the shaft had become separated from the hub due to excessive external mechanical force.It was confirmed that the electrode was not reaching temperature.The probable cause is unintended use error caused or contributed to the event.The shaft was likely damaged by the user pressing too hard.
 
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Brand Name
NA
Type of Device
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
COSMAN MEDICAL, LLC
22 terry avenue
,
burlington MA 01803
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key8075819
MDR Text Key127349671
Report Number3006630150-2018-61846
Device Sequence Number1
Product Code GXI
UDI-Device Identifier00813250010114
UDI-Public00813250010114
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 Physician
Type of Report Initial
Report Date 11/15/2018
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
Device Operator Health Professional
Device Model NumberCSK-TC15
Device Catalogue NumberCSK-TC15
Device Lot NumberL774
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2018
Initial Date FDA Received11/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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