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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION MAGNETIC RETRIEVER SYSTEM
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ATRICURE, INC. COBRA FUSION MAGNETIC RETRIEVER SYSTEM Back to Search Results
Model Number COBRA FUSION MAGNETIC RETREIVER SYSTEM
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4): upon inspection the complaint was confirmed.The magnet housing on the swivel positioner had failed allowing the magnet to become dislodged from the housing.The magnet was returned with the positioner.
 
Event Description
During a procedure, the magnet on the tip of the handle came out of its place, remaining connected to the tip of the fusion 150.The case was completed.The patient care was not affected.
 
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Brand Name
COBRA FUSION MAGNETIC RETRIEVER SYSTEM
Type of Device
COBRA FUSION MAGNETIC RETRIEVER SYSTEM
Manufacturer (Section D)
ATRICURE, INC.
7555 innovation way
mason OH 45040
Manufacturer (Section G)
ATRICURE, INC.
7555 innovation way
mason OH 45040
Manufacturer Contact
anupam bedi
MDR Report Key6655125
MDR Text Key78044762
Report Number3011706110-2017-00054
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K113475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 06/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/01/2019
Device Model NumberCOBRA FUSION MAGNETIC RETREIVER SYSTEM
Device Catalogue Number001-700-003
Device Lot Number69072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2016
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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