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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 Problems Injury (2348); Blood Loss (2597)
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4): no device returned. Product history review could not be performed due to no serial and/or lot information reported. No product malfunction reported during the incident.
 
Event Description
On (b)(6) 2017, a patient received a deep style procedure using a wolf lumitip dissector (mid1) for dissection. While the surgeon was routing the mid1 behind the rpv in an attempt to dissect more tissue between the right pa and the right superior pulmonary vein, he was unable to see the light. At that time, bleeding occurred and the surgeon had to change his approach to a full sternotomy to handle the bleeding. It was determined that the bleed source was from the right superior pulmonary vein, at the junction of the left atrium. The blood loss did not necessitate a blood transfusion during the procedure. The source of the bleeding was closed via suture and the case was able to be completed. The non-atricure product was an endoscopic suction irrigator, to which the surgeon attributed to the bleed. Per the surgeon, the patient was discharged home with no known issues during the remainder of the hospital stay and an uncomplicated prognosis. No device malfunction was reported during the incident. This event is a procedural complication.
 
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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 Key6849169
MDR Text Key85150554
Report Number3011706110-2017-00079
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 Other Health Care Professional
Type of Report Initial
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWOLF LUMITIP DISSECTOR
Device Catalogue NumberA000195
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
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: 09/07/2017 Patient Sequence Number: 1
Treatment
COBRA FUSION, SYNERGY CLAMPS, ATRICLIP PRO2
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