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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, the cautery did not work in vasoview hemopro 2.Another kit was opened and the procedure was successfully completed.No patient injury.No details on any other troubleshooting methods were provided.There was no procedural delay aside from the few minutes to open a new vh-4000 kit.
Additional Manufacturer Narrative
(b)(4).Event site name exceeded character limitations: (b)(6) hospital.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: 50852397
• Report Number: 2242352-2026-0000824
• Device Sequence Number: 9498087
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/22/2026

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: 3000573787
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• 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: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2026
• 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: 72 YR
• Patient Sex: Unknown
• Patient Weight: 151 LB