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

Model Number	VH-6000
Medical Device Problem Codes	Self-Activation or Keying (1557); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that vasoview hemopro 3 was done being used but still plugged in.It started smoking and was burning like left alone.They noticed the jaws of the hemopro 3 was burning when it was in neutral position inside the leg.She took it out immediately and circulating rn unplugged the cord and plugged it back in.As soon as the device was plugged in, the jaw was burning on its own.At this point, we decided the device was not safe to use and opened a new vasoview kit.There was nothing between the jaws that could be associated with the smoking of the tool, such as leftover gauze, fatty tissue, char, or blood.The troubleshooting steps taken were to unplug and replug the tool and then open and use a new kit.The smoke was coming from the jaws.The jaw was observed to be burning.No damage was noticed.The activation toggle was in the neutral state when the smoking and burning of the tool was noticed.The toggle was positioned inside the harvester while the tool was being held by the pa.The harvesting tool was placed in its original box and put away for the representative to pick up.There was no patient harm.An audible beep from the power supply was heard when the smoke was noticed.No injuries.
Additional Manufacturer Narrative
Tw (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 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: 50867403
• Report Number: 2242352-2026-0000829
• Device Sequence Number: 18809902
• Product Code: GEI
• UDI-Device Identifier: 00607567701274
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• 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: Unknown
• Patient Age: 79 YR
• Patient Sex: Male