MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. CAUTERY HIGH TEMP FINE TIP; DISPOSABLE CAUTERY

Model Number	AA01
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.The complaint was able to be confirmed based on information from the user.Root cause is determined to be off label use of the device, as the intended use is to stop small bleeders in hemostasis.This should be considered the final report.If any additional relevant information is identified it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the physician was performing a procedure to implant a vascular graft.During the graft preparation using the subject device (aa01), the heating function at the distal tip gradually weakened, making it impossible to continue the graft shaping operation.The user replaced the device with another unit of the same model and continued the procedure without further issues.There was no harm to the patient, and no procedural delay was reported.".

• Brand Name: CAUTERY HIGH TEMP FINE 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: 24390469
• Report Number: 3002750084-2026-00014
• Device Sequence Number: 10490472
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: AA01
• Device Lot Number: 1124Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/19/2026
• 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