MAUDE Adverse Event Report: Aspen Surgical Products, Inc. Sterile Tip Cleaner; Cautery Tip Cleaner

Model Number	TC-100A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Sterile Tip Cleaner
• Common Device Name: Cautery Tip Cleaner
• 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 ; +1(616)698-7100
• MDR Report Key: 50549613
• Report Number: 3002750084-2026-00089
• Device Sequence Number: 10318200
• Product Code: GEI
• UDI-Device Identifier: 00840113227105
• UDI-Public: 00840113227105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: Other
• Device Model Number: TC-100A
• Device Lot Number: 503068
• 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: 08/02/2026
• Initial Report FDA Received Date: 09/01/2026
• 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