MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO 2 W/VASOSHIELD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-4001

Device Problems Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

One of the cardiac or pa-c's (certified physician¿s assistant) was using this endoscopic vessel harvesting (evh) kit by maquet on a radial harvest.He encountered difficulty passing the endocoagulator and once it was passed and you could see it on the video screen, he saw black debris at the tips of the device.He removed the endocoagulator and another one was opened to replace it.No debris was left in the patient and there was no patient harm.

• Brand Name: HEMOPRO 2 W/VASOSHIELD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11116284
• MDR Text Key: 225063615
• Report Number: 11116284
• Device Sequence Number: 1
• Product Code: GEI
• 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: 12/16/2020

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
• Device Operator: No Information
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 25153273
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1