MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	12-80-40
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the essenz electrical venous occluder (evo).The incident occurred in eindhoven, netherlands.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that an essenz electrical venous occluder (evo) gave an error message at setup related to its motor defective.Once the alarm has been cleared, the unit continued to work properly.There was no patient involvement.
Additional Manufacturer Narrative
H10: the claimed error code is related to a defect in the motor of the occluder.The clamp performs a movability test with a timeframe of 10 minutes when the clamp is not fully closed.If the test failed the notification (error code 2551) is sent from the control unit and it is displayed on the hlm cockpit.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.Therefore, the affected part was returned to manufacturer site for a detailed investigation.The returned unit was fully tested in a climate chamber and no malfunction has been detected: the clamp is functional as per device service manual.Complaints database analysis revealed no similar event since unit installation in march 2023.Based on the investigation results, the most likely root cause of the reported event was an intermittent communication failure between the essenz venous occluder and the control unit.
Event or Problem Description
See initial report.

• Brand Name: ESSENZ ELECTRICAL VENOUS OCCLUDER (EVO)
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17876409
• Report Number: 9611109-2023-00496
• Device Sequence Number: 12558453
• Product Code: DXC
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)230126
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K082344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12-80-40
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown