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	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that the t.W.Power supply was not working correctly during the procedure.The problem that occurred was that the device was not cauterizing.Power setting at 3.There was no change in the power settings, and no adjustment to the settings resolved the issue.The power supply was placed on a shelf near the bovie machine that was not on.The extension cable, adapter, and new harvesting tool kits were changed out; however, the issue persisted and the attempts were unsuccessful.A new device was used to complete the procedure, there was no patient harm.There was a small procedural delay, as the harvest time was lengthened to obtain another device.The power supply is a 2023 unit there is no way of knowing how old their cables and adaptors are because they don't have serial numbers on them.
Additional Manufacturer Narrative
(b)(4).Corrected sections: b5, updated section: b4, e1 (phone #), g3, g6, h2, h11.

• 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: 50559811
• Report Number: 2242352-2026-0000764
• Device Sequence Number: 10098369
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: (01)00607567700826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 08/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 154 LB