MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO2 ADAPTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4020
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (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 the hemopro2 adaptor does not always remain connected to the hemopro power supply and, in some cases, requires taping to ensure consistent energy delivery to the vasoview hemopro 2.The issue happened during the procedure.There was a delay.
Event or Problem Description
The hospital reported that the hemopro2 adaptor does not always remain connected to the hemopro power supply and, in some cases, requires taping to ensure consistent energy delivery to the vasoview hemopro 2.The issue happened during the procedure.There was a delay.No patient harm.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,b5,g3,g6,h2,h6,h11.The reported device is an oem device, therefore, a lot history review was not applicable.A lot number was not provided and the specific product lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

• Brand Name: HEMOPRO2 ADAPTOR
• 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: 24001688
• Report Number: 2242352-2026-0000011
• Device Sequence Number: 10398357
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: (01)00607567700918
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 01/08/2026

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-4020
• Device Catalogue Number: VH-4020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO
• Patient Sex: Unknown