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	10/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A maquet vasoview hemopro was used for vein harvest from the patient's right leg.The physician assistant saw the rubber tip of the hemopro broke off on the camera/monitor, pulled it out from the patient's leg and the piece that broke off was retrieved.There was no patient harm.The piece that broke off from the tip of the hemopro was sent to maquet together with the device.Please also note this is the third report since june 2018 that we have submitted.Re: defective hemopro devices.Manufacturer response for electrosurgical, cutting coagulation accessories, vasoview hemopro (per site reporter).We received an acknowledgement letter from getinge that they have opened complaint to document their investigation.

• 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: 8083890
• Report Number: 8083890
• Device Sequence Number: 11162620
• 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): 11/09/2018
• Report Date (Section F): 11/09/2018

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: 25138761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 69
• Date Report Sent to FDA: 11/09/2018