MAUDE Adverse Event Report: Maquet Cardiovascular LLC T.W. Power Supply; Unit, Cautery, Thermal, Ac-Powered

Model Number	VH-3010
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that the t.W.Power supply stopped heating/cutting/working.Lights of the power supply were lit but no power at the output.The power supply was the only thing that (when traded out) fixed the problem.Power setting was at 3.The issue occurred during the attempt to cauterize the first branch.The device did not shut off after the 15-second activation cycle and was not able to be reactivated after releasing and reengaging the toggle.The age of the hemopro power supply, extension cable, and adapter is unknown, the power supply was placed on the video tower along with the other video equipment during use.The procedure was finished using a different power supply.A few minutes added to time of case due to troubleshooting cables, and kit vs power supply.No patient harm reported.
Additional Manufacturer Narrative
(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.

• Brand Name: T.W. Power Supply
• Common Device Name: Unit, Cautery, Thermal, Ac-Powered
• 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: 50894736
• Report Number: 2242352-2026-0000839
• Device Sequence Number: 6026942
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: (01)00607567700826(11)200708
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052274
• 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
• Report Date (Section B): 09/25/2026

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-3010
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2020
• 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