MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. SKYTRON LUMOS LIGHT HANDLE, STERILE

Model Number	B1-530-17
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has 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 "we have a complaint from the field about disposable rigid handles for lumos lights with holes in the packaging, customer reported 7 handles with a hole in the same location.".
Additional Manufacturer Narrative
The device was returned for evaluation.Visual review of the samples confirmed the failure and it was determined that the pinching occurred during the forming process due to a loose forming tool that occurred during set up of this work order.The root cause is manufacturing error.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: SKYTRON LUMOS LIGHT HANDLE, STERILE
• Common Device Name: LIGHT HANDLE
• 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: 24495983
• Report Number: 3002750084-2026-00025
• Device Sequence Number: 10684839
• Product Code: FTA
• UDI-Device Identifier: 00840113232833
• UDI-Public: 00840113232833
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: B1-530-17
• Device Lot Number: 477476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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