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

Model Number	VH-4000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event site name exceeded character limitations: (b)(6).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
The hospital reported that during use of the vasoview hemopro 2, the metal jaw of the cauterization area detached.The equipment was inspected before use.Before inserting the sampling device, the endoscope is inserted into the cannula.As instructed in the user manual, the jaws of the harvesting tool are closed and inserted with the tips pointing upward.There was no resistance when inserting the sampling device into the cannula.No parts of the device have fallen into the sampling tunnel or into the patient's body.New vasoview hemopro 2 was used to complete the surgery.The procedure was completed without any problems.No health problems were reported for the patients.There was no delay.

• 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: 50931878
• Report Number: 2242352-2026-0000849
• Device Sequence Number: 15843755
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/29/2026

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: 3000547328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2026
• 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 Sex: Unknown