MAUDE Adverse Event Report: BOVIE MEDICAL CORP. REPLACEMENT TIP LOOP; ELECTROCAUTERY TIP LOOP

Model Number	H103
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, no pictures were provided, and the lot code of the product was not provided despite repeated attempts to obtain the information.Due to this, no investigation could be performed, the complaint could not be confirmed, and the root cause could not be determined.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we have had issues with h103 which two patients have been burned.Are you able to assist us with finding a substitute for the product? 2025-06-20 12:04:06 (edt) we are having issues with cautery tip h103 where it has burned patients.".

• Brand Name: REPLACEMENT TIP LOOP
• Common Device Name: ELECTROCAUTERY TIP LOOP
• 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: 22536127
• Report Number: 3007208013-2025-00037
• Device Sequence Number: 12634445
• Product Code: GEI
• UDI-Device Identifier: 00607151071035
• UDI-Public: 00607151071035
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K945758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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: H103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/17/2025
• 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 Sex: Unknown