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

Model Number	VH-4000
Medical Device Problem Codes	Melted (1385); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvest procedure, the harvester was sealing a large vein branch.After energy activation for several seconds, the time-out feature of the device occurred after approximately 15 seconds.Following this, multiple re-activations of energy, with the jaws closed using the spot cautery, occurred due to bleeding from the tunnel wall.Following control of the bleeding, the harvester noticed the jaws of the cautery device "did not look right".After removal of the device from the patient and further inspection, the silicone coating appeared melted and the wire did not appear in its original state.To avoid any potential problems, this device was removed from the field and a new vasoview hemopro 2 was opened.Prior to using the new kit, it was inspected and appeared intact.The new device was used to complete the vessel harvest as expected, without complication.The power setting on the power supply was set to "3".A wet-gauze test was not performed prior to using, however the device did successfully seal several branches prior to the above issue.During branch division, there was an audible beeping sound heard.There was no harm or death to the patient.There was not a significant delay to the overall time of the surgery.
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: 50816508
• Report Number: 2242352-2026-0000815
• Device Sequence Number: 10697071
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: (01)00607567700406(10)3000572594(17)280625
• 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: 3000572594
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 06/26/2026
• 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