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

Model Number	VH-4000
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint was opened as information was received from health canada stating that, during an endoscopic vein harvesting procedure, the vasoview hemopro 2 was not sealing or cutting properly.Considerable bleeding was noted from the posterior-medial branch of the small saphenous vein in the right thigh; approximate blood loss was 200ml.Leg had to be opened: skin subcutaneous incision 15cm in length made.
Additional Manufacturer Narrative
(b)(4).Event site name exceeded character limitations: (b)(6).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.Note: this event contains both an adverse event and a product problem.Due to a temporary system limitation associated with recent fda emdr system enhancements, only the adverse event designation could be transmitted in the current submission.Product problem details are included within this report.A supplemental mdr will be submitted once the emdr utility has been updated to support transmission of both event classifications.

• 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: 50880185
• Report Number: 2242352-2026-0000833
• Device Sequence Number: 15898229
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000556800
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/28/2026
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown