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

Model Number 410-2000

Device Problems Intermittent Continuity (1121); Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

A bovie pad was applied to right lateral thigh.Bovie intermittently not working.Machine replaced and pad contact checked again.When bovie pa was removed a burnt corner was found on the contact pad and patient had a burn from the incident.Physician and bio med notified of incident.

• Brand Name: CONMED BOVIE PAD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 16953624
• MDR Text Key: 315546696
• Report Number: MW5117641
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2023

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 Operator: Health Professional
• Device Model Number: 410-2000
• Device Catalogue Number: (17)241219
• Device Lot Number: 202212205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1