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	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this article 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.
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).Four years, seven months and 14 days later, the patient required a surgical procedure to remove right middle ear foreign body using an operating microscope and epidisc.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
The device referenced in this article 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.
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).Four years, seven months and 14 days later, the patient required a surgical procedure to remove right middle ear foreign body using an operating microscope and epidisc.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 updated to provide investigation findings and corrected data.Corrected data is reported in b1 and h1.New information is reported in h6 and h10.The device will not be returned per intake information.If and when the device is returned, the complaint will be reopened and updated with the information from the physical evaluation.Due to the serial number not being provided by the customer, a device history record (dhr) review can not be conducted by olympus.As the device will not be returned for evaluation it is difficult to conclude a definitive root cause of the customer phenomenon , however, probable cause of the reported failure could be attributed to the incision made for the insertion of the device.The device has flange arms that are supposed to sit outside of the incision to ensure proper extrusion.When the incision is made too big, this promotes the skin to enclose the device and hence move the device into the middle ear.To extract the device, surgery is required, which is outside the scope of this device.An investigation was completed by the oem (supplier) and it was determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be user application of the device.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
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 13001463
• Report Number: 3003790304-2021-00189
• Device Sequence Number: 1508179
• 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: 2017
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: UNKNOWN
• 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: 01/18/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/31/2022
• 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: 7 YR
• Patient Sex: Female