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	01/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During vein harvesting for open heart surgery, the scrub stated it stopped working and when it was pulled out by the physician's assistant, it looked defective.Manufacturer response for electrosurgical, cutting coagulation accessories, vasoview hemopro (per site reporter) they have acknowledged receipt of the device and assigned complaint reference #.

• 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: 9810762
• Report Number: 9810762
• Device Sequence Number: 14004579
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: (01)00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/27/2020
• Report Date (Section F): 02/27/2020

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: Health Professional
• Device Model Number: VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25147966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 02/27/2020