MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. KITTNER, SINGLE TIP, STERILE; ENDOSCOPIC KITTNER

Model Number	KT-9101
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 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.
Additional Manufacturer Narrative
The device was returned for evaluation.The root cause was a manufacturing error.The kittner device penetrated the pouch seal.The production line was reviewed and it was determined that it is possible to turn the line speed up too far, without the operator realizing it, and that could produce weaker seals.Based on this, the production has been moved to a different seal machine to prevent that from occurring again.All lots in inventory were reviewed, and all were repackaged on the accu-sealer (different seal machine) to ensure that any existing inventory would not have the same concern.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: KITTNER, SINGLE TIP, STERILE
• Common Device Name: ENDOSCOPIC KITTNER
• 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: 23593808
• Report Number: 3002750084-2025-00059
• Device Sequence Number: 13292044
• Product Code: GCJ
• UDI-Device Identifier: 00840113214006
• UDI-Public: 00840113214006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K913500
• 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): 01/13/2026

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: Other
• Device Model Number: KT-9101
• Device Lot Number: 476684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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