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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a tympanostomy procedure, the tula delivery system could not be successfully deployed.The failure occurred in a cleft patient that had very small and undeveloped anatomy.The eardrum was angled so it was not possible to get direct apposition of the tds device for a successful deployment.After 2 attempts on the same ear using a unilateral kit, the procedure was aborted.Revision surgery in the or was scheduled.The outcome is unknown.
Additional Manufacturer Narrative
H11: correction in b5 and h6 (health effect - impact code).
Event or Problem Description
It was reported that during a tympanostomy procedure, the tula delivery system could not be successfully deployed.The failure occurred in a cleft patient that had very small and undeveloped anatomy.The eardrum was angled so it was not possible to get direct apposition of the tds device for a successful deployment.After 2 attempts on the same ear using a unilateral kit, the procedure was aborted.A surgery in the or was scheduled.The outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 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.Insufficient product information was available therefore a manufacturing record review could not be performed.A complaint history review found no 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.A clinical evaluation was performed and concluded based on the available information no further action is required at this time.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.

• 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: 17410474
• Report Number: 3012130335-2023-00001
• Device Sequence Number: 12548860
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2023

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 Catalogue Number: TDS114G
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/06/2023; 09/08/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/03/2023; 09/15/2023
• 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 Sex: Unknown