MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC MAQUET VASOVIEW FOR ENDOSCOPIC VEIN HARVESTING; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number 2151801

Device Problems Smoking (1585); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/18/2020

Event Type  malfunction  

Event Description

During endoscopic vein harvesting, the surgeon noted that there was more smoke than usual.And then it wouldn't cauterize.The generator and cable were changed out and the problem continued- they opened another vasoview and swapped out the cautery tool.Once that happened it worked properly.There was no harm to the patient.

• Brand Name: MAQUET VASOVIEW FOR ENDOSCOPIC VEIN HARVESTING
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10902651
• MDR Text Key: 218220259
• Report Number: 10902651
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2151801
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA