MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 1401628

Device Problem Continuous Firing (1123)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

When setting up equipment for surgery, surgical tech passed of electrical surgical unit (esu) pencil.Nurse plugged into esu machine #1401628 that was set to 30/30/30.When the nurse plugged in the pencil, she heard a noise that signaled the machine was being activated.She immediately unplugged and plugged it into the next slot, and it continued to be activated.At this point the surgical tech was holding the pencil in her hand and stating that the pencil was firing without being depressed and asked if the pedal was being pressed accidently.The nurse unplugged it and checked to see if the pedal had something on it to cause it to fire.The pedal was free and clear and there was nothing on it to cause it to fire.The esu was at that point unplugged and removed from the room and a new esu machine was brought in, a new esu grounding pad was applied to a different site and a new esu pencil was placed on the field.At this point the surgical tech noticed that there was an approximate ½ inch mark noted to the upper inner area of the calf that was not there prior to this occurrence.

• Brand Name: BOVIE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton rd; clearwater FL 33760
• MDR Report Key: 16477632
• MDR Text Key: 310627249
• Report Number: 16477632
• 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: 02/13/2023

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: 1401628
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25915 DA
• Patient Sex: Female
• Patient Race: White