MAUDE Adverse Event Report: UNKNOWN BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problem Foreign Body In Patient (2687)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

During open heart surgery, the cardiac surgeon was taking down the left internal mammary artery when she noticed the plastic cover of the bovie tip feel off inside the chest.The surgeon claimed, "this is not the first time it happened." item retrieved.All affected product with this lot number was removed from inventory and sequestered.New inventory with a different lot number was ordered as a replacement.Both the distributor and manufacture were notified by purchasing/supply chain of the incident and are working on resolving the issue.Product appears to be defective and the manufacture will conduct analysis to determine the issue.

• Brand Name: BOVIE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18858311
• MDR Text Key: 337373938
• Report Number: MW5152472
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 137 KG