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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. ENCOMPASS SYNERGY CLAMP (LONG)
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ATRICURE, INC. ENCOMPASS SYNERGY CLAMP (LONG) Back to Search Results
Model Number OLH
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2023
Event Type  malfunction  
Manufacturer Narrative
The product history record was reviewed for lot 128576.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.
 
Event Description
A patient underwent a coronary artery bypass graft (cabg) with posterior wall encircling ablation.During procedure, the plunger insert of the closure lever detached and fell on to the surgical drapes.The procedure was completed with the device.No patient harm reported.
 
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Brand Name
ENCOMPASS SYNERGY CLAMP (LONG)
Type of Device
ENCOMPASS SYNERGY CLAMP (LONG)
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 Key17361901
MDR Text Key319893938
Report Number3011706110-2023-00028
Device Sequence Number1
Product Code OCL
UDI-Device Identifier30840143904800
UDI-Public(01)30840143904800(17)260301(10)128576
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K210477
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOLH
Device Catalogue NumberA001143
Device Lot Number128576
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/12/2023
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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