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
Additional Manufacturer Narrative
The device has just been 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 "sterilized failure".
Additional Manufacturer Narrative
The actual device was returned for evaluation.A review of the sample confirms that the issue was cause by seal interference due to trim scrap entering the seal during the pouch manufacturing process.The line does not have sensors to alert operators when a slit cut occurs.If operators do not identify and remove the resulting trim scrap, it can wrap around the chain and attach to subsequent product causing seal interference.The root cause is manufacturing error.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: 22911974
• Report Number: 3002750084-2025-00044
• Device Sequence Number: 9110794
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 449824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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