MAUDE Adverse Event Report: American Eagle Instruments American Eagle Instruments; AEEP23/12BX, EXPL/PROBE 23/12 (Black)(3/8)

Model Number	AEEP23/12BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, during a cleaning procedure, the explorer tip broke from aeep23/12bx lot fs6 broke and was swallowed by the patient.The patients daughter took him to the hospital and they were told he would need surgery to remove the tip.It was believed that would happen the same day and he would have to stay the night in the hospital.On (b)(6) 2026 the dental office called back with an update.The patient was sedated for the procedure and the tip was removed.The patient is doing okay.
Additional Manufacturer Narrative
Section a: patient information boxes 1 (patient identifier), 4 (weight), 5 (ethnicity), and 6 (race) were not provided due to patient confidentiality reasons.Section b box 6 (relevant tests) at the time of this report, the instrument was not returned to conduct additional testing.Section g.4 no bla or 510k for this device.

• Brand Name: American Eagle Instruments
• Common Device Name: AEEP23/12BX, EXPL/PROBE 23/12 (Black)(3/8)
• Manufacturer (Section D): American Eagle Instruments; 6575 butler creek rd; missoula MT 59808
• Manufacturer (Section G): American Eagle Instruments; 6575 butler creek rd; missoula MT 59808
• Manufacturer Contact: conor vegge ; 6575 butler creek rd; missoula, MT 59808 ; +1(406)532-7301
• MDR Report Key: 50442985
• Report Number: 1000127001-2026-00001
• Device Sequence Number: 9780046
• Product Code: EIX
• UDI-Device Identifier: 00841013104794
• UDI-Public: 00841013104794
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AEEP23/12BX
• Device Catalogue Number: AEEP23/12BX
• Device Lot Number: FS6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male