MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW EVH ACCSESSORY PACK; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	VH-2004
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The vasoview endoscopic vessel harvesting system's insufflator would not hold pressure inside the patient and the veins could not be visualized.Open vein harvesting was done.

• Brand Name: VASOVIEW EVH ACCSESSORY PACK
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 20383054
• Report Number: 20383054
• Device Sequence Number: 8066105
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: (01)00607567700376(17)260101(10)3000363621
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/03/2024
• Report Date (Section F): 10/03/2024

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: Other
• Device Model Number: VH-2004
• Device Catalogue Number: VH-2004
• Device Lot Number: 3000363621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Date Report Sent to FDA: 10/03/2024