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

Model Number	12-80-10
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the electrical venous occluder (evo) clamp.The incident occurred in (b)(6) finland.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 electrical venous occluder (evo) clamp gave an error message associated to a faulty encoder at its the first use by the customer during procedure.It was replaced with a loaner unit.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: the affected part was returned to livanova deutschland for a detailed investigation.The unit was inspected and the issue was confirmed.In order to solve it, the encoder was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Most likely root cause of the reported event can be trace back to a faulty encoder.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO) CLAMP
• 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: 16384948
• Report Number: 9611109-2023-00068
• Device Sequence Number: 12185984
• Product Code: DXC
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)220829
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/15/2023

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: 12-80-10
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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