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

Model Number VH-3000

Device Problems Smoking (1585); Failure to Shut Off (2939); Temperature Problem (3022); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2019

Event Type  malfunction  

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8631062
• MDR Text Key: 145757247
• Report Number: 8631062
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: (01)00607567700345(17)200326(10)25145699
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA