MAUDE Adverse Event Report: BOVIE MEDICAL CORP. MCKESSON COATED EXTEN MOD BLADE; DISPOSABLE CAUTERY

Model Number	22-ES39T
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are attempting to get the device returned for evaluation.The investigation is ongoing.Once additional relevant information is identified it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "one of our surgeons is wanting to try new electrode blades so i ordered argent (mckesson-has both names on it) ref # 22-es39t lot 1124z and we had a major issue with it during a case.The plastic protector over the blade started to melt so we discontinued using the product.".
Additional Manufacturer Narrative
The device was not returned for evaluation.Based on responses from the user, the complaint was able to be confirmed.The user was operating at a setting beyond what the device is capable of handling, per the ifu, causing the insulation on the blade to fail.The root cause is user error.If any additional rellevant information is identified, it will be submitted in a supplemental report.

• Brand Name: MCKESSON COATED EXTEN MOD BLADE
• 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: 22513201
• Report Number: 3007208013-2025-00031
• Device Sequence Number: 13073264
• Product Code: GEI
• UDI-Device Identifier: 20612479210107
• UDI-Public: 20612479210107
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: 22-ES39T
• Device Lot Number: 1124Z
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Supplement 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: Unknown