MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. VESSEL LOOPS; RED; MAXI; NON-STERILE; BULK; 1X406MM

Model Number	011011BBI
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "vessel loops are of poorer, thinner quality.They are too elastic and are not closing off the blood vessels.".
Additional Manufacturer Narrative
The device was not returned for evaluation, no pictures were provided, and the lot code was not provided.The complaint could not be confirmed, and no root cause was established.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: VESSEL LOOPS; RED; MAXI; NON-STERILE; BULK; 1X406MM
• 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: 24306119
• Report Number: 3002750084-2026-00013
• Device Sequence Number: 9660902
• Product Code: KDC
• UDI-Device Identifier: 00840113228942
• UDI-Public: 00840113228942
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 03/17/2026

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: 011011BBI
• Device Lot Number: UNKNOWN
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/17/2026
• 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