MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2400
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event site telephone exceeds character limitations: (b)(6).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported that the surgeon unpacked the vasoview 6 pro and checked it using the ifu (initial function unit) ¿ the vasoview 6 pro didn't work.The vasoview 6 pro could not be activated, the harvester replaced the bipolar cable, but that didn't work either.A new kit was opened, connected to the bipolar cable and the new kit worked perfectly.Per attached photos there is no visible issue with the device.There was no delay.There was no patient harm.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11 the lot # 3000511548 history record review was completed.There was an ncmr , rework, or deviation documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW 6 PRO
• 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: 24795846
• Report Number: 2242352-2026-0000238
• Device Sequence Number: 9538022
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000511548(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K091733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2026

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-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000511548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/12/2026; 05/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/12/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Male
• Patient Weight: 110 KG