MAUDE Adverse Event Report: PRECEPTIS MEDICAL, INC. HUMMINGBIRD TYMPANOSTOMY TUBE SYSTEM; TYMPANOSTOMY TUBE AND INSERTER

Model Number	05-1001-653
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinician reported placing ear tubes in her clinic in a 4-year old female patient using the hummingbird tympanostomy tube system.The system was used to successfully place a tympanostomy tube (tt) in the first ear.In the second ear, the child's head moved slightly during the procedure, causing the tube to be delivered medially into the middle ear space.The clinician attempted to retrieve the tt, but was not able to extract it during the procedure in the office.An operating room follow-up to locate and extract the tube under general anesthesia was scheduled.The follow-up procedure was not able to locate the tt in the middle ear space.The doctor reports that patient has no symptoms related to the medialized tube and there is no adverse impact on patient hearing.Patient will be monitored for symptoms and appropriate action taken if any occur.
Additional Manufacturer Narrative
The internal complaint reference for this incident is (b)(4).The insertion device involved was discarded by the customer and is not available for evaluation.Patient motion during the procedure is a known risk of the in-office ear tube procedure.Instructions for use and clinician training process both address the need for patient stabilization during the procedure.Risk management review was conducted and the reported harm has been appropriately documented in the risk management file.Dhr and complaint review for the lot number involved did not reveal any issues that would have contributed to this incident.

• Brand Name: HUMMINGBIRD TYMPANOSTOMY TUBE SYSTEM
• Common Device Name: TYMPANOSTOMY TUBE AND INSERTER
• Manufacturer (Section D): PRECEPTIS MEDICAL, INC.; 8401 wayzata blvd; suite 110; golden valley MN 55426
• Manufacturer (Section G): PRECEPTIS MEDICAL, INC.; 8401 wayzata blvd; suite 110; MN 55426
• Manufacturer Contact: steve anderson ; 8401 wayzata blvd; suite 110; golden valley, MN 55426 ; 7635687809
• MDR Report Key: 19455287
• Report Number: 3010610937-2024-00001
• Device Sequence Number: 7106727
• Product Code: ETD
• UDI-Device Identifier: 00853386007077
• UDI-Public: 00853386007077
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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 Expiration Date: 05/04/2025
• Device Model Number: 05-1001-653
• Device Lot Number: L-1101818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 16 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White