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

Model Number	E4-4112
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
At end of procedure, the resident attempted to place bridle and was having difficulty.Second resident attempted to help place bridle.Magnet from bridle was lost in patient.Ent was consulted.Ent pa was unable to visualize foreign body.X-ray was taken.Foreign body was seen on x-ray of patient's head.Ent attending came to operating room (or) for emergent foreign body retrieval.Attending was unsuccessful.Both attendings agreed patient was safe to be extubated.Attendings agreed to schedule a ct scan for patient and notify nursing staff to monitor patient's expectant for foreign body.

• Brand Name: AMT BRIDLE¿
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 8054625
• Report Number: 8054625
• Device Sequence Number: 16590974
• Product Code: KNT
• UDI-Device Identifier: 00842071103958
• UDI-Public: (01)00842071103958
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/02/2018
• Report Date (Section F): 11/02/2018

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: E4-4112
• Device Catalogue Number: E4-4112, 4-4112
• Device Lot Number: 171222-324
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/02/2018