MAUDE Adverse Event Report: BOVIE MEDICAL CORP. SUCTION COAGULATOR, DISP, HANDSWITCH; ELECTROSURGICAL SUCTION COAGULATOR

Model Number	SCH12
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is in process of being returned.Investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "while using the suction bovie that came in the ent pack, the doctor got a burn from the handle by the suction below the button, not the tip.It burned through her glove and on her finger.".
Additional Manufacturer Narrative
The device was returned, and then was sent out for external evaluation.We are still awaiting the results, and the investigation is ongoing.Once new relevant information is identified, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The actual device that allegedly malfunctioned was not returned.Devices from the same box and lot were returned for evaluation.Those were sent out for testing and passed all tests, working as intended.True root cause is undetermined, as the complaint could not be confirmed.A possible root cause could be related to the device being used at a near 90 degree angle against the patient, causing body fluid to flow into the intake port during suction and creating a conductivity path between the electrode through the back-flowed liquid to the physicians hand when the device is being activated.Per the ifu, it is not recommended to activate the device with the electrode vertically down at a 90 degree angle to the patient.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: SUCTION COAGULATOR, DISP, HANDSWITCH
• Common Device Name: ELECTROSURGICAL SUCTION COAGULATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: terry hall ; 5115 ulmerton road; clearwater, FL 33760 ; 6166987100
• MDR Report Key: 22063759
• Report Number: 3007208013-2025-00019
• Device Sequence Number: 8348151
• Product Code: GEI
• UDI-Device Identifier: 00607151006549
• UDI-Public: 00607151006549
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K033003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: SCH12
• Device Lot Number: 240306152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/18/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown