MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. VESSEL LOOPS; WHITE; SUPERMAXI; STERILE

Model Number	011021PBX
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in process of being returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "imperfect seal of the pouch.-open channel / large sealing void in the pouch seal.-inner pouch was caught in the outer pouch seal.".
Additional Manufacturer Narrative
The device was returned for evaluation.It was confirmed that the inner pouch was correctly sealed.However, evidence of interference in the sealing area of the outer pouch was identified, attributable to the inner pouch being partially positioned within the sealing area at the time of final closure.The root cause is manufacturing error, specifically inconsistent execution of the visual verification prior to sealing, which allowed this condition to go undetected and resulted in incomplete sealing of the outer pouch.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: VESSEL LOOPS; WHITE; SUPERMAXI; STERILE
• Common Device Name: VESSEL LOOPS
• 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: 23760096
• Report Number: 3002750084-2025-00064
• Device Sequence Number: 10091093
• Product Code: KDC
• UDI-Device Identifier: 00840113229260
• UDI-Public: 00840113229260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/28/2026

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: 011021PBX
• Device Lot Number: 479208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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