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

Model Number	VH-4030
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that harvester noticed that branches were taking longer than expected to ligate and not sealing during ligation phase of evh.Occurred near the end of the whole leg harvest.Hemopro 2 extension cable swapped to complete the last couple of branches.Harvester tested unit prior to use.Power setting placed at 3.No additional complaints after vh-4030 swapped for the completion of the procedure.No patient injury reported.
Additional Manufacturer Narrative
(b)(4).Event site name event site name exceeds 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.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b4, d4, g3, g6, h2, h6, h11.The device was not returned to maquet cardiac surgery for investigation; therefore, no evaluation could be performed.It is not possible to confirm the reported complaint.
Event or Problem Description
N/a.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• 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: 24256543
• Report Number: 2242352-2026-0000043
• Device Sequence Number: 15540232
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: (01)00607567700925
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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-4030
• Device Catalogue Number: VH-4030
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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 CONCOMITANT PRODUCTS WERE USED.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 95 KG