MAUDE Adverse Event Report: Maquet Cardiovascular LLC VasoView Hemopro 2; Electrosurgical, Cutting & Coagulation & Accessories

Model Number	VH-4000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a cabg a vasoview hemopro 2 continuously timing out.Power setting at 3.The toggle was fully slid backward to deliver energy to the jaws, and a ¿click¿ was felt to indicate activation of the device.The procedure was completed successfully with a very minor case delay of 2 minutes.A new device was used to complete the procedure.There was no patient harm.
Additional Manufacturer Narrative
(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

• Brand Name: VasoView Hemopro 2
• Common Device Name: Electrosurgical, Cutting & Coagulation & Accessories
• Manufacturer (Section D): Maquet Cardiovascular LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): Maquet Cardiovascular LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 50838992
• Report Number: 2242352-2026-0000818
• Device Sequence Number: 13249218
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: VH-4000
• Device Catalogue Number: VH-4000
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Unknown
• Patient Sex: Unknown