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	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the cauterizer remained active, and further investigation revealed a leaking battery.".
Additional Manufacturer Narrative
The device was not available for evaluation.The complaint was able to be confirmed based on information received from the end user.The root cause is determined to be a leaking battery that allowed the button to fall in and leave the device active.The root cause of why the battery leaked is unable to be determined with accuracy at this time.This should be considered the final report.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: 24011968
• Report Number: 3002750084-2026-00002
• Device Sequence Number: 14674757
• Product Code: HQP
• UDI-Device Identifier: 00607151011055
• UDI-Public: 00607151011055
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/08/2026
• 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