MAUDE Adverse Event Report: TUSKER MEDICAL INC. TULA TDS 1.14 GROMMET; TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Catalog Number	TDS114G
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Based on the limited information provided, the clinical root cause of the reported events cannot be definitively concluded, and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The patient impact beyond the reported is not anticipated since the procedure was reportedly aborted and rescheduled after three (3) unsuccessful attempts to place the tubes.If the additional tubes were retained, biocompatibility is not an issue as the tubes are implantable devices.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted currently.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during a tympanostomy procedure, upon deploying the tube of the tula device, the surgeon noticed he did not hear an audible click and he felt that the blade did not extrude fully to make an incision and the tube short shot (b)(4).Upon retrieval of the tube he tried again with the second tds from the tula kit and it had the same result (b)(4).He then tried a third time with a tds from a different kit and it also failed (b)(4).After the third attempt the procedure was aborted and rescheduled for the or.No additional complications were reported.

• Brand Name: TULA TDS 1.14 GROMMET
• Common Device Name: TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG
• Manufacturer (Section D): TUSKER MEDICAL INC.; 155 jefferson drive; menlo park CA 94025
• Manufacturer (Section G): TUSKER MEDICAL INC.; 155 jefferson drive; menlo park CA 94025
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18114903
• Report Number: 3012130335-2023-00002
• Device Sequence Number: 6988890
• Product Code: QJA
• UDI-Device Identifier: 00840128600047
• UDI-Public: 840128600047
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P190016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TDS114G
• Device Lot Number: 21110101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 11/10/2023
• 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
• Patient Sex: Unknown