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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. WOLF LUMITIP DISSECTOR

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ATRICURE, INC. WOLF LUMITIP DISSECTOR Back to Search Results
Model Number WOLF LUMITIP DISSECTOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 06/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4) there were no device malfunction reported, all devices functioned as expected. The device was not returned for evaluation and no device history review was done as no lot number was provided.
 
Event Description
A (b)(6) male underwent deep style vats maze procedure was heparinized, and off pump at the start of procedure. The surgeon had a mid1 around the pv and could see the light from the mid1, while attempting to outage the dial to articulate the mid1, he lost sight of the light and then observed blood. Surgeon made an immediate call to convert to a sternotomy. The bleed was from the posterior la that was corrected with suturing. There was an unknown amount of blood loss but not enough to necessitate a transfusion. There was approximately an hour added to the case. The doctor attributes the bleed to thin, delicate tissue giving rise to push through during dissection.
 
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Brand NameWOLF LUMITIP DISSECTOR
Type of DeviceWOLF LUMITIP DISSECTOR
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 Key6689394
MDR Text Key79151298
Report Number3011706110-2017-00059
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberWOLF LUMITIP DISSECTOR
Device Catalogue NumberA000195
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
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 Treatment Data
Date Received: 07/06/2017 Patient Sequence Number: 1
Treatment
MAX5,EML2,EMR2,CRYO2
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