MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Model Number AA01

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

Fine tip cautery had a fire flare when used.

• Brand Name: BOVIE
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 3034 owen drive; antioch TN 37013
• MDR Report Key: 17718614
• MDR Text Key: 323052595
• Report Number: 17718614
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2023,09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AA01
• Device Catalogue Number: AA01
• Device Lot Number: 1022Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2023
• Date Report to Manufacturer: 09/11/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44530 DA