MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. MEDLINE ANTI-FOG (EU), STERILE

Model Number	MD-1001E
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in process of trying to get the device 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 "product appears to be less effective, resulting in blurred images during laparoscopic procedures.This problem has occurred twice.".
Additional Manufacturer Narrative
The device was not available for evaluation, and no pictures were provided, resulting in the complaint not being able to be confirmed.The fog solution from lot 453252 underwent a functional test prior to shipping, and it passed and was within specification.No root cause could be determined due to not having samples to retest.However, the most probable root cause for such an event would be from environmental temperature changes during transit of the fog solution to the customer as that could cause the solution to be less effective.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: MEDLINE ANTI-FOG (EU), STERILE
• Common Device Name: ANTI-FOG
• 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: 23878621
• Report Number: 3002750084-2025-00063
• Device Sequence Number: 9464176
• Product Code: OCT
• UDI-Device Identifier: 00840113214822
• UDI-Public: 00840113214822
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K932449
• 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): 01/30/2026

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: MD-1001E
• Device Lot Number: 453252
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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