MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE

Model Number	LT-F01B
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "sterilized failure".
Additional Manufacturer Narrative
The actual device was returned for evaluation.The root cause was manufacturing error.Product was caught in the seal, preventing a proper seal and compromising the sterility of the package.The exact cause is not clear, but most likely is due to a combination of product shifting on the manufacturing line, not detecting the protrusion, and the operator not catching and removing the improperly sealed product.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE
• Common Device Name: LIGHT HANDLE COVER
• 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: 22114347
• Report Number: 3002750084-2025-00022
• Device Sequence Number: 7062748
• Product Code: FTA
• UDI-Device Identifier: 00840113200955
• UDI-Public: 00840113200955
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: LT-F01B
• Device Lot Number: 442265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/30/2025
• 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