MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. HIGH FREQUENCY ESU 40 WATT GENERATOR; ELECTROSURGICAL GENERATOR

Model Number	A940
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in process of trying to get the device returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "when using a bipolar catheter to stop bleeding from a patient's eyelid, it ignited at the tip.The patient's upper eyelashes were burned.".

• Brand Name: HIGH FREQUENCY ESU 40 WATT 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: 25337080
• Report Number: 3002750084-2026-00054
• Device Sequence Number: 14772414
• Product Code: GEI
• UDI-Device Identifier: 10607151005334
• UDI-Public: 10607151005334
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: A940
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 31 YR
• Patient Sex: Female