MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BOVIE® SPECIALIST PRO HIGH FREQ GENERATOR; ELECTROSURGICAL GENERATOR

Model Number	A1250S
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in process of being returned for evaluation and repair, and the investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "error code e-4 - would not work during procedure".
Additional Manufacturer Narrative
The device was returned for evaluation and repair.When tested, it was found that an electronic circuit board/module within the unit needed to be replaced as it was the source of the malfunction.Once replaced, the unit was subjected to release testing and passed all testing and was found to be acceptable for use.The root cause was an electronic circuit board malfunction.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: BOVIE® SPECIALIST PRO HIGH FREQ GENERATOR
• Common Device Name: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 23980337
• Report Number: 3002750084-2026-00001
• Device Sequence Number: 10606078
• Product Code: GEI
• UDI-Device Identifier: 00607151010263
• UDI-Public: 00607151010263
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K022856
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: A1250S
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown