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	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, and no pictures of the device were provided.Without these, the investigation was very limited.The complaint could not be confirmed, and no root cause could be established.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 artificial blood vessel could not be severed due to insufficient thermal conductivity.".

• 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: 24714233
• Report Number: 3002750084-2026-00032
• Device Sequence Number: 5740281
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: AA05
• Device Lot Number: 0525Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/30/2026
• 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