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	10/15/2021
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.
Event or Problem Description
The physician reports two cases of duravent tube migration to the middle ear.For this case, the patient underwent a bilateral myringotomy and tympanostomy (m+t).Three years, four months later, the patient required a surgical procedure to remove right middle ear foreign body using an operating microscope.No further consequences to the patient have been reported.Case with patient identifier (b)(6) reports patient 1/2.Case with patient identifier (b)(6) reports patient 2/2.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the legal manufacturer's investigation and the inability to evaluate the device, the root cause of the implanted tubing migrating into the inner ear could not be identified.However, it is possible that the incision size made for insertion of the duravent tube and/or the trimming of the duravent tube for insertion was the cause.Per the legal manufacturer's instructions for use: if the incision is made too large, the duravent tube can migrate into the middle ear.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 ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 13001503
• Report Number: 3003790304-2021-00190
• Device Sequence Number: 14522355
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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?: No
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 6 YR
• Patient Sex: Male