MAUDE Adverse Event Report: BOVIE MEDICAL CORP. RESISTICK II COATED MOD BLADE ELECTRODE 2.75IN

Model Number	ES37T
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "for the past year, we've been performing umbilical hernia surgeries with this protected electrocautery blade, and we have been fully satisfied with it.However, for the past month, surgeons have started reporting that when they begin the surgery (after the incision with the scalpel), they proceed with the protected blade electrocautery.They start the dissection using the cut function on the electrocautery, and the cautery turns on along with the connected smoke evacuator.However, the tissues are not being cauterized.Everything works fine with the coag function, but the cut function doesn't work.Sometimes, the surgeon injects the tissues with marcaine at the beginning of the surgery, but we do not notice any difference in conduction whether the infiltration occurs at the start or the end of the procedure.".
Additional Manufacturer Narrative
The device is in process of being returned for evaluation, and the investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was returned and tested, and no issues were noted with the device as it passed all testing.The complaint was unable to be confirmed, and root cause is undetermined.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: RESISTICK II COATED MOD BLADE ELECTRODE 2.75IN
• 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: 23716096
• Report Number: 3007208013-2025-00065
• Device Sequence Number: 13007468
• Product Code: GEI
• UDI-Device Identifier: 00607151005757
• UDI-Public: 00607151005757
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: ES37T
• Device Lot Number: 0424Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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