MAUDE Adverse Event Report: Maquet Cardiovascular LLC VasoView Hemopro 3; Electrosurgical, Cutting & Coagulation & Accessories

Model Number	VH-6000
Medical Device Problem Code	Smoking (1585)
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 an endoscopic vein harvesting procedure using the vasoview hemopro 3, after completing the radial artery harvest, they unplugged and moved the hemopro 3 kit to begin the vein harvest.They plugged the hemopro 3 plug into the power unit.After a minute or so, the hemopro 3 started to produce a lot of smoke.(the tips were closed and within the sheath when it began producing smoke.) the sheath is the white handle of the kit where the hemopro3 is inserted down the shaft.The hemopro 3 was unplugged and taken off the field.They used the same device for both the radial artery and vein harvest.They were keeping the jaws clean after moving from the radial artery to the vein harvest.The defective device was inspected prior to use.The smoke was not noticed while cauterizing the branches.Two different power supplies were used, one for the vein harvest and one for the radial artery harvest.The power supply was tested by biomed.When smoking with no one touching it there was no sound.Power supply light was on.Cable led not sure.A device pre-test (activating the device on wet gauze) was not performed prior to use on the patient.There was no resistance noted while inserting the harvesting tool into the cannula.The hp3 power supply had been previously used with other hp3 devices prior to testing.There were no attempts to change out the hemopro 3 power supply.A new device was used instead.When the new device was plugged in, there were no issues.The smoke is coming from the hemopro3 jaws.There was no delay.There was no patient harm.
Additional Manufacturer Narrative
(b)(4) the device has been returned to the factory and will be evaluated.A supplemental report will be submitted when the evaluation is completed.

• Brand Name: VasoView Hemopro 3
• 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: 50817602
• Report Number: 2242352-2026-0000817
• Device Sequence Number: 10152132
• Product Code: GEI
• UDI-Device Identifier: 00607567701274
• UDI-Public: (01)00607567701274(10)3000560822(17)280512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251238
• 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: Other Health Care Professional
• 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-6000
• Device Catalogue Number: VH-6000
• Device Lot Number: 3000560822
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2026
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 158 LB