MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. VESSEL LOOPS, WHILE, SUPERMAXI, STERILE 1.3X559MM

Model Number	011021PBX
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
Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device is available for evaluation, and the manufacturing lot number was provided for review.The investigation is ongoing.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the sterile packaging is open.".
Additional Manufacturer Narrative
The actual device was not returned for evaluation, however pictures of the seal concern were provided.Also, part number and lot number were provided.There are seal verification procedures in place, and it was determined that they were not being carried out correctly before continuing with the next stage.The root cause is manufacturing error.The operators have been retrained, and new documentation controls have been implemented to indicate that the sealing operation was performed correctly, and by whom.If any additional relevant information is identified, it will be included in a supplemental report.

• Brand Name: VESSEL LOOPS, WHILE, SUPERMAXI, STERILE 1.3X559MM
• 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: 20579437
• Report Number: 3002750084-2024-00044
• Device Sequence Number: 18273022
• Product Code: KDC
• UDI-Device Identifier: 00840113229260
• UDI-Public: 00840113229260
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 02/12/2025

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: 400652
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 02/12/2025
• 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