MAUDE Adverse Event Report: GYRUS ACMI, INC. ARM BEV VENT TB FLPL .045 [ORIG ITEM: 140242] (6/PK); INSERTER, MYRINGOTOMY TUBE

Model Number	140242-ENT
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that the surgeon did not like the arm bev vent tb flpl.045 device as the rim that held the ear tube in place was not sturdy enough.When asked further, it was stated that on one occasion in november or december of 2022, the tube had fallen into a hole in the eardrum.There was no patient injury reported.Additional information has been requested.
Additional Manufacturer Narrative
Olympus received a box of the devices, but has not yet received the complaint device.The outer box already was opened, but all the 6 sterile packets inside are brand new and still in sealed condition.Each vent tube was examined under a microscope and found no appearance abnormalities.A measurement was taken inside the tube¿s diameter by using a test caliper, reading at 1.14mm which is within the inner diameter specification.The beveled inner flange, hollow cylinder and its rims appeared to be sturdy when pressed down with tweezers.The device can stand upright firmly on either side without an issue.Based on the evaluation findings, the reported complaint was not confirmed.The device met its specification.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, although the customer reported that the tube fell into the patient¿s middle ear, all six devices returned for an evaluation were unused.Therefore, it is likely that the subject device belonged to another box of devices.Due to this, the root cause of the reported event could not be determined.This supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: ARM BEV VENT TB FLPL .045 [ORIG ITEM: 140242] (6/PK)
• Common Device Name: INSERTER, MYRINGOTOMY 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: 16742660
• Report Number: 3003790304-2023-00153
• Device Sequence Number: 6539992
• Product Code: JYM
• UDI-Device Identifier: 00821925035027
• UDI-Public: 00821925035027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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: 140242-ENT
• Device Lot Number: 341697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/26/2023; 06/20/2024
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/11/2023; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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 Sex: Unknown