MAUDE Adverse Event Report: GYRUS ACMI, INC. UNKNOWN; TYMPANOSTOMY TUBE

Model Number	245775
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that this tympanostomy tube had migrated to middle ear and skin healed over it.A surgical intervention was performed to remove a foreign body in left middle ear and an ear patch was applied.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This device will not be returned for evaluation as it was discarded.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide correction to the initial (d4 and h5) and an update to field (h4).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the suggested event occurred due to the user's application of the device, rather than any manufacturing, material, or processing issues.However, the subject device was not returned, and the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: UNKNOWN
• Common Device Name: TYMPANOSTOMY TUBE
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16791880
• Report Number: 1037007-2023-00017
• Device Sequence Number: 14875818
• Product Code: ETD
• UDI-Device Identifier: 00821925018143
• UDI-Public: 00821925018143
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 245775
• Device Lot Number: MH690912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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: Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female