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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that when harvester had completed dissection and was taking branches he did experience the vasoview hemopro 2 shutting down after some prolonged burning, but the it did not recover at all with rest.The power supply was changed out with no effect.At that point, a new hemopro 2 was opened and that one worked as expected.Power supplies set at 3.There was an audible beep from the power supply during activation when the difficulty cutting branches occurred.They were unable to determine whether both lights on the power supply were illuminated.The toggle was fully slid backward to deliver energy to the jaws.The hp2 does not have a tactile click to indicate activation.There was a delay due to switching out the components and finally having to open another kit.There was no patient harm or adverse effects.
Additional Manufacturer Narrative
Tw (b)(4) event site name exceeds 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: 50815001
• Report Number: 2242352-2026-0000812
• Device Sequence Number: 10218574
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: (01)00607567700406(10)3000574938(17)280706
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/18/2026

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: 3000574938
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• 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: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2026
• 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: No concomitant medical products needed.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 156 LB