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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 001-700-003
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 07/21/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was received and sent to atricure engineering for analysis.The complaint was confirmed the magnet was dislodged from the end of the device.
 
Event Description
It was reported by the sales rep.That during an minimally invasive case, the products magnet fell off into the patient and was recovered and removed.The surgeon utilized another device to proceed with the procedure.The patient outcome 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.
west chester OH
Manufacturer Contact
john huff
6217 centre park drive
west chester, OH 45069
5136444725
MDR Report Key5004150
MDR Text Key23148260
Report Number3003502395-2015-00028
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
Reporter Occupation Not Applicable
Report Date 07/21/2015
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 Number001-700-003
Device Lot Number13316-042314
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/23/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? 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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