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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 10/20/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4) - complaint was confirmed.The device was returned with the plunger insert detached.
 
Event Description
On (b)(6) 2023 a patient underwent a myectomy with concomitant maze using an olh clamp.While using the olh, the blue plunger insert of the closure lever detached and fell into sterile field, away from chest cavity, and then fell to the floor.Procedure was completed with the device and there was no reported harm to the patient.
 
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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 
5136448220
MDR Report Key18113662
MDR Text Key328157492
Report Number3011706110-2023-00047
Device Sequence Number1
Product Code OCL
UDI-Device Identifier10840143905834
UDI-Public(01)10840143905834(17)260601(10)131473
Combination Product (y/n)N
Reporter Country CodeUS
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 11/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2023
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 Number131473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2023
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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