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)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 during an endoscopic vein harvesting procedure, vasoview 6 pro bipolar coagulation was defective.When using the coagulation rod of the vasoview 6 pro for the first time, they always test it on a piece of fat to check whether the bipolar clamp works or not.This did not work.Then they asked for another bipolar cable to see if this was the cause.But it still did not work.Then they asked the circulating nurse to pull the plug of the bipolar cable and turn it around, but it still did not work.Then they decided in consultation with the surgeons to give another vasoview 6 pro.The bipolar did work on the new one.The patient did not suffer any damage or injuries, but there is valuable time was lost because of this.
Additional Manufacturer Narrative
(b)(4).Updated section b4, b5, g3, h2, h11.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro bipolar coagulation was defective.A new vasoview was taken during the procedure.The device did not deliver energy.As a result, i could not burn and then cut through side branches of the vein.When using the coagulation rod of the vasoview 6 pro for the first time, they always test it on a piece of fat to check whether the bipolar clamp works or not.This did not work.Then they asked for another bipolar cable to see if this was the cause.But it still did not work.Then they asked the circulating nurse to pull the plug of the bipolar cable and turn it around, but it still did not work.Then they decided in consultation with the surgeons to give another vasoview 6 pro.The bipolar did work on the new one.The patient did not suffer any damage or injuries, but there is valuable time was lost because of this.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw #(b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11.The lot # 3000424329.History record review was completed.There was an ncmr 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.

• 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: 22063411
• Report Number: 2242352-2025-0000605
• Device Sequence Number: 15406978
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000424329(17)261118
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2025

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: 3000424329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 07/24/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/13/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: NO.
• Patient Sex: Unknown