MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. CAUTERY HIGH TEMP 2IN EXTENDED SHAFT LOOP TIP; DISPOSABLE CAUTERY

Model Number	AA05
Medical Device Problem Code	Failure to Power Up (1476)
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 the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "to begin cauterization, it is necessary to press the green button after opening the lid.However, in this case, the button was already recessed from the beginning, making it impossible to initiate the cauterization.The procedure was completed with the replacement.No adverse health consequences to the patient occurred.".
Additional Manufacturer Narrative
The device was returned for evaluation.Root cause is determined to be a failed battery inside the device, that was unable to deliver power to the unit, corrosion that caused the brass rod to erod, which caused the green button to be pressed in.Further analysis into what caused the battery to fail is unable to be determined at this time.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: CAUTERY HIGH TEMP 2IN EXTENDED SHAFT LOOP TIP
• Common Device Name: DISPOSABLE CAUTERY
• 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: 24777415
• Report Number: 3002750084-2026-00031
• Device Sequence Number: 6064254
• Product Code: HQP
• UDI-Device Identifier: 00607151011055
• UDI-Public: 00607151011055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121441
• 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): 05/08/2026

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: AA05
• Device Lot Number: 0323U
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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