MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	VH-3000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician's assistant (pa) was using the vasoview hemopro endoscopic vessel harvesting system while conducting an endoscopic vein harvest, and when the provider attempted to use this device to cauterize a vein, the unit had no conduction, which means the physician's assistant was unable to close up the vein.Operating room team had to open a new unit, which worked as intended.

• Brand Name: VASOVIEW HEMOPRO
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9086151
• Report Number: 9086151
• Device Sequence Number: 11377371
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2019
• Report Date (Section F): 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25144599
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/09/2019