MAUDE Adverse Event Report: COVIDIEN COVIDIEN VALLEYLAB PENCIL (BOVIE PENCIL); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/20/2023

Event Type  Injury  

Event Description

The reported event was that the surgeon noticed arcing while using a handheld covidien valleylab pencil (bovie pencil), that caused a minor skin burn to the patient, and also burned the surgeon.While activating the erbe electrical surgical unit (esu) it was noticed to have a greater than usual patient effect and arcing occurred.This resulted in the minor skin burns to the patient and the surgeon.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COVIDIEN VALLEYLAB PENCIL (BOVIE PENCIL)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 17984489
• MDR Text Key: 326249180
• Report Number: MW5147233
• 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: 10/18/2023

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: 10/23/2023
• Patient Sequence Number: 1