MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED

Model Number	VH-3010
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (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
The hospital reported that at the beginning of the procedure the cautery of the vasoview hemopro 2 kept cutting in and out during point of use.Extension cord was replaced but issue kept occurring.A new t.W.Power supply was substituted which resolved the problem.Beeping was heard intermittently.T.W.Power supply set at level 2.Pre-cautery test not performed.Patient was not injured during the case.No procedural delay was indicated.The device did not shut off after the 15-second activation cycle.Power setting at 2.There was no change in settings that resolved this issue.The power supply was placed on the tower near the light source and c02 insufflator, as in every other hospital.

• 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: 25135359
• Report Number: 2242352-2026-0000338
• Device Sequence Number: 9316315
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: (01)00607567700826(11)240823
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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-3010
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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
• Patient Sex: Unknown