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

Model Number SEP6000

Device Problem Device Remains Activated (1525)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2023

Event Type  malfunction  

Event Description

Bovie pencil kept firing on its own, no buttons were pressed, and it would go off.

• Brand Name: VALLEYLAB BOVIE PENCIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16991559
• MDR Text Key: 315832793
• Report Number: 16991559
• Device Sequence Number: 1
• Product Code: GEI
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SEP6000
• Device Lot Number: 2110286X
• 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: 05/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Sex: Female