MAUDE Adverse Event Report: LivaNova Deutschalnd Electronic Venous Occluder; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Model Number	ELCTRNC VENOUS OCCLDR UNIT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that electronic venous occluder (evo) displayed an error code indicating that it was not working properly during procedure.Reportedly, error acknowledgement temporarily cleared after cleaning procedure and then it reappeared.There was no patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.H11 livanova deutschland manufactures the evo clamp, the event occurred in japan.Through follow up communication it was learned that the displayed error was related to a faulty encoder (e1538).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: Electronic Venous Occluder
• Common Device Name: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Manufacturer (Section D): LivaNova Deutschalnd; lindberghstraße 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LivaNova Deutschland; lindberghstraße 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 50189946
• Report Number: 9611109-2026-90363
• Device Sequence Number: 9887538
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: ELCTRNC VENOUS OCCLDR UNIT
• Device Catalogue Number: 12-80-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 12/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown