MAUDE Adverse Event Report: CONMED CORPORATION CONMED BOVIE UNIT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 60-2450-120

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 08/10/2021

Event Type  No Answer Provided  

Event Description

Bovie pencil shocked surgeon.

• Brand Name: CONMED BOVIE UNIT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 12414100
• MDR Text Key: 270096941
• Report Number: MW5103686
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-2450-120
• Device Catalogue Number: 2450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1