MAUDE Adverse Event Report: BOVIE MEDICAL CORP. CAUTERY HIGH TEMP 2IN EXTENDED SHAFT; DISPOSABLE CAUTERY

Model Number	AA05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned for evaluation, however pictures were provided.The root cause is determined to be an isolated incident from this lot, where the abs plastic tube moved down the brass poles.It is a manufacturing error for not having a tight enough fit.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 "during a cardiovascular surgery on (b)(6) 2025, while using a disposable cautery device, aa05 (#0923z), the tube protecting the metal part slipped off on its own and touched the electrified part, causing it to burn.Since the tube is not supposed to move, the doctor judged it to be defective and stopped using it immediately.An another aa05 (#0923z) was used instead, and it was worked without any issues.".

• Brand Name: CAUTERY HIGH TEMP 2IN EXTENDED SHAFT
• Common Device Name: DISPOSABLE CAUTERY
• 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: 22236007
• Report Number: 3007208013-2025-00021
• Device Sequence Number: 15500359
• Product Code: HQP
• UDI-Device Identifier: 00607151011055
• UDI-Public: 00607151011055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: AA05
• Device Lot Number: 0923Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/17/2025
• 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