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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 SURGICAL SYSTEM
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ATRICURE, INC. COBRA FUSION 150 SURGICAL SYSTEM Back to Search Results
Model Number 001-700-001S
Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was received and sent to atricure engineering for analysis.The complaint was confirmed, and the magnet dislodged from the end of the device.
 
Event Description
It was reported during a procedure while manipulating the fusion probe in the patient with the ball end rotating device, the magnet, located in the distal end of the probe became detached.It was located and removed from the patient prolonging the procedure an additional 15 minutes.The patient outcome was not affected.
 
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Brand Name
COBRA FUSION 150 SURGICAL SYSTEM
Manufacturer (Section D)
ATRICURE, INC.
west chester OH
Manufacturer Contact
john huff
6217 centre park dr.
west chester, OH 45069
5136444725
MDR Report Key4976067
MDR Text Key22514603
Report Number3003502395-2015-00025
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
PMA/PMN Number
K113475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Not Applicable
Report Date 07/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number001-700-001S
Device Lot Number14072-0490915
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/31/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received07/06/2015
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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