MAUDE Adverse Event Report: MAQUET GETINGE GROUP / MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-3000

Device Problems Failure to Shut Off (2939); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2020

Event Type  malfunction  

Event Description

During endovascular vein harvest, the harvesting tool malfunctioned.The toggle switch was stuck in the on position preventing it from being turned off.This was discovered prior to using it on the patient.No patient harm occurred.New harvesting tool obtained to complete the procedure.Fda safety report id# (b)(4).

• Brand Name: VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET GETINGE GROUP / MAQUET CARDIOVASCULAR, LLC; 45 barbour pond dr; NJ 07470
• MDR Report Key: 10020483
• MDR Text Key: 189880479
• Report Number: MW5094345
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2021
• Device Model Number: VH-3000
• Device Lot Number: 25150292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 81