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

Model Number	VH-2400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (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 product failure for vasoview 6 pro.
Additional Manufacturer Narrative
(b)(4).Updated fields: b4, b5,d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11.The device was returned to the factory for evaluation on 12/13/2024.An investigation was conducted on 01/15/2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact c-ring.The bipolar blades were observed to be intact.The cutter blade was observed to be extended.There were no visual defects observed on the intact cutter blade.The toggle was manipulated to retract and extend the cutter blade.The cutter blade would not retract.Based on the returned condition of the device, and the no specific failure reported, the analyzed failure "mechanical problem " was observed.An engineer evaluation was conducted.A visual inspection was conducted.The device showed signed and clinical use.Upon further investigation, it was noted that when the rocker ((b)(4)) was actuated the blade on the bisector subassembly ((b)(4)) was not moving.This was noted as not a normal function of the device.The device was disassembled and it was observed that the pullrod ball ((b)(4)) was detached from the rocker arm ((b)(4)).It was also noted that there was an obstruction impeding the full retraction of the blade.Conclusion: the pullrod ball detaching from the rocker arm was due to the obstruction impeding the travel of the blade.Impeding travel of the blade correlates to more force needing to applied to the rocker and can potentially lead to the pullrod ball popping out of the rocker arm socket.The lot # 3000416465 history record review was completed.There was an ncmr, rework, or deviations 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 none specific reported failure.
Event or Problem Description
The hospital reported product failure for vasoview 6 pro.No injuries reported.

• 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: 20902814
• Report Number: 2242352-2024-0001342
• Device Sequence Number: 15711478
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000416465(17)260830
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2025

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 Expiration Date: 08/30/2026
• Device Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000416465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: UNKNOWN.
• Patient Sex: Unknown