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
Additional Manufacturer Narrative
The device has been returned for evaluation, and the investigation is ongoing.Once we have additional relevant information we will submit it in a supplemental report.
Event or Problem Description
Complainant alleges "sterilized failure".
Additional Manufacturer Narrative
The device was returned for evaluation.The tip cleaner was caught in the seal, causing a sterility seal failure.The root cause is most likely operator error as the operator manually loads each tip cleaner into the pouch.If any additional relevant information is identified it will be submitted in a supplemental report.

• 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 ; 6166987100
• MDR Report Key: 24248002
• Report Number: 3002750084-2026-00006
• Device Sequence Number: 13160025
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: Other
• Device Model Number: TC-100A
• Device Lot Number: 485281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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