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

Model Number	VH-4000
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that the vasoview hemopro 2 smoke would not evacuate from the tunnel at the beginning of the vein harvest.Pre-cautery test was not performed.A new vasoview hemopro 2 was used to successfully complete the procedure.Patient was not injured.No additional time was added to the procedure.
Additional Manufacturer Narrative
Tw (b)(4) event site name exceeded character limitations: (b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

• 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: 50882379
• Report Number: 2242352-2026-0000836
• Device Sequence Number: 21509111
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: (01)00607567700406(10)3000572920(17)280626
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Lot Number: 3000572920
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2026
• 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: None
• Patient Sex: Unknown