MAUDE Adverse Event Report: BOVIE MEDICAL CORP / SYMMETRY SURGICAL INC. BOVIE MONOPOLAR CAUTERY PEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/16/2023

Event Type  Injury  

Event Description

The reported event was that a patient was burned when a bovie monopolar cautery pen was connected to the erbe electrical surgical unit (esu) generator.The customer indicated that they used the bovie cautery too close to a metal clamp which caused the energy to arc and burn the patient.The burns were found around and under the metal clamp.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BOVIE MONOPOLAR CAUTERY PEN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOVIE MEDICAL CORP / SYMMETRY SURGICAL INC.
• MDR Report Key: 18076416
• MDR Text Key: 327533619
• Report Number: MW5147810
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Patient Sequence Number: 1