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	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw#: (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable energy stopped being delivered during the ligation phase.Power source swapped without resolution of the problem.Vh-4030 was then swapped while using the original power source and harvester was able to complete the procedure without further incident.No patient injury reported.Minimal delay during troubleshoot but no material delay to procedure.
Additional Manufacturer Narrative
Tw # (b)(4) updated sections: b4,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 08/08/2025.An investigation was conducted on 08/13/2025.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact cable.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2 evh tool, reference adapter and reference power supply set at level 3.0.The device failed the pre-cautery test.The power supply did not emit an audible beeping sound and the evh returned harvesting tool did produce steam and heat.Based on the returned condition of the device as well as the evaluation results, the reported failure "electrical /electronic property problem" was confirmed.A manufacturing engineer evaluation was conducted.The complaint was not confirmed.A reference hemopro 2 device was connected to the complaint lab's hemopro power supply (c-vh-3010), hemopro2 adapter (c-vh-4020), and hemopro2 extension cable (c-vh-4030).The on/off power switch on the hemopro power supply (c-vh- 3010) was moved to the on position and the toggle on the handle of the vh-4000 hemopro2 tool was pulled back to the activation (power on) position.The hemopro power supply immediately started making an audible beeping sound that indicated electrical energy was being delivered to the reference hemopro 2 device.Wet gauze was placed between the jaws and there was visible steam.The reference hemopro 2 device was then connected to the same hemopro power supply (c-vh-301o), the same hemopro 2 adapter, and the complaint hemopro2 extension cable (onetrack 1155798).The on/off power switch on the hemopro power supply (c-vh-3010) was moved to the on position and the toggle on the handle vh-4000 hemopro2 tool was pulled back to the activation (power on) position.The hemopro power supply immediately started making an audible beeping sound that indicated electrical energy was being delivered to the reference hemopro 2 device.Wet gauze was placed between the jaws and there was visible steam.The complaint hemopro 2 extension cable passed the heat up test confirming that the extension cable is performing as intended and able to deliver energy.Based on the manufacturing engineering evaluation, the reported failure "electrical /electronic property problem" was not confirmed.See attached manufacturing engineering evaluation memo.The reported device is an oem device, therefore, a lot/serial history review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.
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: 22794347
• Report Number: 2242352-2025-0000933
• Device Sequence Number: 12840763
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: (01)00607567700925
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/13/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown