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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 ABLATION SYSTEM
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ATRICURE, INC. COBRA FUSION 150 ABLATION SYSTEM Back to Search Results
Model Number 001-700-001S
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was received and sent to atricure engineering for analysis.The complaint was confirmed, upon evaluation the magnet cap had failed resulting in the magnet pulling from the distal end of the probe.
 
Event Description
It was reported by the sales rep.That the magnet fell out of the device at the end of the case.When the magnet came out, it was drawn to the metal retractor and that is where they were able to grab it.
 
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Brand Name
COBRA FUSION 150 ABLATION SYSTEM
Type of Device
COBRA FUSION 150 ABLATION SYSTEM
Manufacturer (Section D)
ATRICURE, INC.
6217 centre park dr.
west chester OH 45069 3886
Manufacturer Contact
ranjana iyer
6217 centre park dr.
west chester, OH 45069-3886
5137555328
MDR Report Key5798935
MDR Text Key49755321
Report Number3003502395-2016-00041
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 11/06/2015
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 Number001-700-001S
Device Catalogue Number001-700-001S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/06/2015
Initial Date FDA Received07/15/2016
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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