MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT INITIAL PLACEMENT DILATOR SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	IP-DIL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dilator set number #7, dilator in the pack doesn't have a lumen to go into the guidewire.

• Brand Name: AMT INITIAL PLACEMENT DILATOR SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 22043730
• Report Number: 22043730
• Device Sequence Number: 8880155
• Product Code: KNT
• UDI-Device Identifier: 00842071106867
• UDI-Public: (01)00842071106867(17)270501(10)240815-240
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2025
• Report Date (Section F): 05/08/2025

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: Health Professional
• Device Model Number: IP-DIL
• Device Catalogue Number: IP-DIL
• Device Lot Number: 240815-240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 MO
• Patient Sex: Female
• Patient Weight: 5 KG
• Date Report Sent to FDA: 05/08/2025