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	04/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The physician assistant was using the vasoview hemopro endoscopic vessel harvesting system by maquet, ref# (b)(4), to acquire a length of vein for bypass surgery.While using the cautery of the scissor tip, smoke appeared.While the jaws of the scissor were open, the cautery activated.The scissor (cautery device) was removed from use and a new one was opened.Handwritten on the device box after the incident: "cautery activating while tips open and tips expelling smoke." manufacturer response for electrosurgical, cutting coagulation accessories, vasoview hemopro (per site reporter).The maquet rep.Is forwarding the device issue.

• 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: 8503141
• Report Number: 8503141
• Device Sequence Number: 222806
• 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): 04/04/2019
• Report Date (Section F): 04/04/2019

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: 25144649
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 04/04/2019