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)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports a patient had an adenoidectomy and right ear duravent tube placement , no issues reported.One year, and 17 days later, the patient required a myringotomy and tympanostomy (m+t) procedure and foreign body retrieval (of the duravent ear tube) due to migration of the duravent into the middle ear.There were no additional consequences to the patient reported.
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The investigation does not suggest product non-conformances during manufacturing processes.Based on the results of the investigation, a possible root cause is the use error when trimming the duravent tube for the procedure.If the incision is made too large, the device may migrate into the middle year.However, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: kenneth pittman ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13172828
• Report Number: 3003790304-2022-00003
• Device Sequence Number: 4780677
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 02/08/2022

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: NC799934
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female