• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRICURE, INC. WOLF LUMITIP DISSECTOR Back to Search Results
Model Number MID1
Device Problem Use of Device Problem (1670)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/20/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The mid1 device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the mid1 device was not reported or able to be ascertained.
 
Event Description
On (b)(6) 2022 a female patient underwent a procedure for inappropriate sinus tachycardia (ist). When the surgeon retracted the mid1 device the left atrium was injured. The procedure was converted to a sternotomy and the patient placed on cardiopulmonary bypass to repair the injury. There were no known post-operative complications. This was a procedural complication. There was no reported device malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
john ehlert
7555 innovation way
mason, OH 45040
5136448220
MDR Report Key14461927
MDR Text Key293364327
Report Number3011706110-2022-00018
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMID1
Device Catalogue NumberA000195
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
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: 05/20/2022 Patient Sequence Number: 1
-
-