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	05/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Male patient in operating room for cabg.During the endoscopic vein harvest, the vasoview hemopro electrocautery device became stuck in the "on" position, causing the electrodes to become "red-hot" and smoke to be seen when the device had not been activated.The device was quickly disconnected from the generator to stop the energy delivery.Team obtained a new device and continued the procedure.Unable to observe any obvious patient damage or injury.Per the team, one thing that could have been done to prevent this from getting to the patient is a bench test by the scrub, which was not done.The bench test involves either dunking the tip in saline, or grasping a saline moistened sponge and test firing the device, observing steam rise and stopped when button is released.

• 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: 8631062
• Report Number: 8631062
• Device Sequence Number: 1924636
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: (01)00607567700345(17)200326(10)25145699
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/15/2019
• Report Date (Section F): 05/15/2019

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-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25145699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/15/2019