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

Model Number	SCH08
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "suction cautery was arching off to the side, not connected to any tissue, during our ent (ear, nose, throat) procedure.Faulty equipment.Continued to use device with caution.This has never happened before with the suction cautery product.".
Additional Manufacturer Narrative
The device is not available for return.The investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was not returned for evaluation, no pictures were provided, and no lot number was provided.The complaint could not be confirmed, and no root cause was able to be determined.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: SUCTION COAGULATOR, DISP, HANDSWITCH
• Common Device Name: 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: 22144751
• Report Number: 3007208013-2025-00022
• Device Sequence Number: 8391879
• Product Code: GEI
• UDI-Device Identifier: 00607151006525
• UDI-Public: 00607151006525
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 07/10/2025

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: SCH08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 27 YR
• Patient Sex: Male