MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. EZ CLEAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0013M

Device Problems Improper or Incorrect Procedure or Method (2017); Sparking (2595)

Patient Problem Burn, Thermal (2530)

Event Date 09/24/2019

Event Type  malfunction  

Event Description

The installation on the bovie tip wasn't inserted completely and had exposed electrodes that burned the lower right lip.Interventions were established right away.Ointment was applied and steroids injected to site.The surgeon informed family of the incident.We really aren't sure what caused the spark.The surgeon believes it to be user error in that the bovie tip was not properly placed into the bovie pen.It was a new tip that was opened, not the one that comes with the original bovie pen.Since we weren't sure whether it was product defect or user error we just decided to cover all avenues and have the bovie machine itself looked at by biomed, fill out a product defect form for the bovie tip, and fill out an internal report.However, the report is addressing the bovie machine only, not the tip.

• Brand Name: EZ CLEAN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s state st; draper UT 84020
• MDR Report Key: 9238814
• MDR Text Key: 163768067
• Report Number: 9238814
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2019

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 Catalogue Number: 0013M
• Device Lot Number: 194055
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13140 DA