MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT BRIDLE¿ PRO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	E4-420810
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While trying to bridle the pt.'s duotube, it was discovered that one of the magnets fell off the end when trying to remove and reposition the stylets.The magnet was connected to the opposite stylet upon removal.

• Brand Name: AMT BRIDLE¿ PRO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 22211394
• Report Number: 22211394
• Device Sequence Number: 15640701
• Product Code: KNT
• UDI-Device Identifier: 00842071115876
• UDI-Public: (01)00842071115876
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/06/2025
• Report Date (Section F): 06/06/2025

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: E4-420810
• Device Catalogue Number: E4-420810, 4-420810
• 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: 06/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Date Report Sent to FDA: 06/06/2025