MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT INITIAL PLACEMENT DILATOR SET; Tubes, gastrointestinal (and accessories)

Model Number	IP-DIL
Medical Device Problem Codes	No Apparent Adverse Event (3189); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to medsun report #: (b)(4) which was received by amt from the fda on 05/19/2025.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt worked with the original reporter to obtain the device for examination and performed an inspection of the device once returned.Examination of the device was unable to confirm the reported complaint that the 7 french dilators did not have a lumen.Examination found the device was hollow as intended.Clamp marks were found on the outer diameter of the tip of the dilator.It is believed that during placement the dilator tip was clamped down on with forceps, or an equivalent instrument, which compressed the inner diameter making it difficult or impossible to pass a guidewire through at the time of compression.During inspection, a guidewire was able to pass through the length of the returned dilator with no issues.Review of the complaint record found that this is the first reported complaint of its kind.The complaint information has been logged into our complaint database for trending purposes.Information regarding device investigation can be found under complaint #(b)(4).
Event or Problem Description
Per the original reporter in uf #: (b)(4), it was reported that the, "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 boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 22141527
• Report Number: 1526012-2025-00007
• Device Sequence Number: 17907488
• Product Code: KNT
• UDI-Device Identifier: 00842071106867
• UDI-Public: 00842071106867
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K073034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/04/2025
• 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 Age: 10 MO
• Patient Sex: Female
• Patient Weight: 5 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American