MAUDE Adverse Event Report: BOVIE MEDICAL CORP. RESISTICK II COATED MOD BLADE ELECTRODE 2.5 IN

Model Number	ES59T
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "we were doing a cervical case yesterday with a neurosurgeon dr.(b)(6) who used the short insulated bovie tip that disintegrating with use.The bovie unit was set on 35 cut 35 coag.".
Additional Manufacturer Narrative
The device was not returned for evaluation, however the complaint was able to be confirmed from pictures and information provided.The root cause is determined to be user error, as use of coagulation mode of the device at 35 watts for 10 seconds of activation will cause the tip to get hot enough to melt the insulation.This should be considered the final report.If any additional relevant information is identified, it will be submitted ina supplemental report.

• Brand Name: RESISTICK II COATED MOD BLADE ELECTRODE 2.5 IN
• Common Device Name: BLADE ELECTRODE
• 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: 22820889
• Report Number: 3007208013-2025-00042
• Device Sequence Number: 20999342
• Product Code: GEI
• UDI-Device Identifier: 00607151005726
• UDI-Public: 00607151005726
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093025
• 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): 08/15/2025

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: ES59T
• Device Lot Number: 0323U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/15/2025
• 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: Female