MAUDE Adverse Event Report: ETHICON / MEGADYNE MEDICAL PRODUCTS, INC. BOVIE FOOT PEDAL; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2023

Event Type  Injury  

Event Description

When attempting to use the foot pedal on the ethicon megadyne loaner bovie, md asked staff to check the bovie because the coag was not working on the bovie.Machine was checked and foot pedal removed and reapplied.Coag still did not work.A different bovie had to be brought in.

• Brand Name: BOVIE FOOT PEDAL
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): ETHICON / MEGADYNE MEDICAL PRODUCTS, INC.
• MDR Report Key: 16789291
• MDR Text Key: 313811525
• Report Number: MW5116884
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/17/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White