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

Model Number	VH-4020
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned to the factory and will be evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
Related to (b)(4).The hospital reported that during the procedure, the power stopped working in the hemopro 2 adaptor.There was no harm.No delay was reported.
Event or Problem Description
The hospital reported that during the procedure the power stopped working in the hemopro2 adaptor.There was no harm.No delay was reported.The case was completed by taping up the adaptor to a perpendicular position to the tower.It was able to function and finish the case in that way.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,b5,d4-exp date, udi#,g3,g6,h2,h3,h4,h6,h11.The device was returned to the factory for evaluation on 03/02/2026.An investigation was conducted on 03/04/2026.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 adaptor.Both connectors were observed to be intact.An electrical evaluation was conducted.The adapter was connected to a reference power supply vh-3010 and reference extension cable with no visual or physical difficulties.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 passed the pre-cautery test.The power supply did emit an audible beeping sound and the evh reference tool did produce steam or heat.An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073.The device successfully transected tissue four (4) times.Based on the returned condition of the device, investigation results, the reported failure "failure to deliver energy" was not confirmed.The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

• 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: 24618569
• Report Number: 2242352-2026-0000184
• Device Sequence Number: 13158183
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: (01)00607567700918(11)250620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/17/2026

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
• Device Lot Number: 02506128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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: UNKNOWN.
• Patient Sex: Unknown