MAUDE Adverse Event Report: GYRUS ACMI, INC DURAVENT VT TB 1.27MM TP (60/PK); TUBE, TYMPANOSTOMY

Model Number	245775
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.Investigation activities have been opened to manage the actions related to remediation of this issue and any required mdr reporting.
Event or Problem Description
It is reported an unspecified time frame after a procedure to implant a duravent tympanostomy tube, the tube migrated to the inner ear and required surgical intervention to remove it.No additional consequences to the patient have been reported as a result of this occurrence.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The definitive root cause of the issue where the implanted tubing migrated into the inner ear could not be definitively determined.However, an investigation was completed by the original equipment manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Although the device was not made available for evaluation, failure can likely be attributed to the incision made for the implant.If the incision was too large, it would cause the flanges of the implant to not be positioned outside of the incision.The large incision would cause the skin to grow over the implant and migrate into the middle ear.Olympus will continue to monitor the field performance of this device.

• Brand Name: DURAVENT VT TB 1.27MM TP (60/PK)
• Common Device Name: TUBE, TYMPANOSTOMY
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11862125
• Report Number: 1037007-2021-00041
• Device Sequence Number: 14563858
• Product Code: ETD
• UDI-Device Identifier: 00821925018143
• UDI-Public: 00821925018143
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention