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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 1500 ABLATION SYSTEM; COBRA FUSION 150 ABLATION SSYTEM
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ATRICURE, INC. COBRA FUSION 1500 ABLATION SYSTEM; COBRA FUSION 150 ABLATION SSYTEM Back to Search Results
Model Number 700-001S
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/15/2015
Event Type  malfunction  
Event Description
It was reported during a procedure, the electrodes dislodged from the device.The electrodes did not fall into the patient and there was no adverse consequence.The result was a slight delay in the procedure to open another device.
 
Manufacturer Narrative
(b)(4).The device has not yet been returned to atricure for evaluation.If additional information is received a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(4).Upon inspection the device had 12 electrodes pulled from the assembly which were on both the active and indifferent sides of the device.The complaint was confirmed.
 
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Brand Name
COBRA FUSION 1500 ABLATION SYSTEM
Type of Device
COBRA FUSION 150 ABLATION SSYTEM
Manufacturer (Section D)
ATRICURE, INC.
west chester OH
Manufacturer Contact
john huff
6217 centre park dr.
west chester, OH 45069
5136444725
MDR Report Key4535643
MDR Text Key5507289
Report Number3003502395-2015-00011
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Not Applicable
Type of Report Initial,Followup
Report Date 01/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number700-001S
Device Catalogue Number700-001S
Device Lot Number13701-102414
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? Yes
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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