MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MONOPOLAR CAUTERY PEN; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/09/2023

Event Type  Injury  

Event Description

The reported event was that after a da vinci-assisted surgical procedure, a patient burn was noticed at the port site.The customer initially reported that the burn was from the erbe generator.Upon additional follow-up it was noted that the surgeon was using a bovie monopolar cautery pen during port placement.The size of the burn was reportedly ¿small¿ with an unknown severity and was treated with burn ointment.Disclaimer statement: 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: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): BOVIE MEDICAL CORP.
• MDR Report Key: 18011388
• MDR Text Key: 326697368
• Report Number: MW5147332
• Device Sequence Number: 1
• Product Code: HQP
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1