MAUDE Adverse Event Report: TUSKER MEDICAL INC. UNKNOWN; TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Catalog Number	UNKNOWN
Medical Device Problem Codes	Premature Activation (1484); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tympanostomy, during the iontophoresis, the surgeon double clicked on both channel buttons to enter "reduce mode" and the fault indicator lit up and the control unit stopped working.The surgeon insisted to use another control unit and utilized a spare to complete the iontophoresis.After it was completed, the surgeon deployed the tube delivery system in which a "short shot" occurred.The surgeon promptly removed the tube from the ear canal, and utilized a replacement tds device.They tried to move on to the next ear and due to the patient´s temperament, the procedure was aborted and re-scheduled in the operating room.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.D4, lot no.: the following are the part numbers & lot numbers of the two devices reported: part number: 72290103/lot number: tug17241, part number: 72290097/lot number: unknown.D4, exp.Date: expiration dates for each of the 2 lot numbers reported: 18-oct-2025 (part number: 72290103/lot number: tug17241) & unknown (part number: 72290097/lot number: unknown).D4, unique identifier (udi) #: unique identifier number for each of the two devices reported: (b)(4) (part number: 72290103) & (b)(4) (part number: 72290097).H4, mgf.Date: manufacturing dates for each of the 2 lot numbers reported: 24-apr-2024 (part number: 72290103/lot number: tug17241) & unknown (part number: 72290097/lot number: unknown).D1: brand name was changed to unknown due to the two devices reported: (72290103) tula control unit spare (nst007065) & (72290097) tula tds 1.14 grommet (str007011).
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.D4, lot no.: the following are the part numbers & lot numbers of the two devices reported: part number: 72290103/lot number: tug17241, part number: 72290097/lot number: unknown.D4, exp.Date: expiration dates for each of the 2 lot numbers reported: 18-oct-2025 (part number: 72290103/lot number: tug17241) & unknown (part number: 72290097/lot number: unknown).D4, unique identifier (udi) #: unique identifier number for each of the two devices reported: (b)(4) (part number: 72290103) & (b)(4) (part number: 72290097).H4, mgf.Date: manufacturing dates for each of the 2 lot numbers reported: 24-apr-2024 (part number: 72290103/lot number: tug17241) & unknown (part number: 72290097/lot number: unknown).D1: brand name was changed to unknown due to the two devices reported: (72290103) tula control unit spare (nst007065) & (72290097) tula tds 1.14 grommet (str007011).
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.D4, lot no.: the following are the part numbers & lot numbers of the two devices reported: part number: 72290103/lot number: tug17241, part number: 72290097/lot number: unknown.D4, exp.Date: expiration dates for each of the 2 lot numbers reported: 18-oct-2025 (part number: 72290103/lot number: tug17241) & unknown (part number: 72290097/lot number: unknown).D4, unique identifier (udi) #: unique identifier number for each of the two devices reported: (b)(4) (part number: 72290103) & (b)(4) (part number: 72290097).H11: h2: corrected data on: b1, b2 & h10.

• Brand Name: UNKNOWN
• 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: 20301458
• Report Number: 3012130335-2024-00007
• Device Sequence Number: 20764929
• Product Code: QJA
• UDI-Device Identifier: 00885556817742
• UDI-Public: 885556817742
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/25/2024

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 Catalogue Number: UNKNOWN
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 09/05/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 09/25/2024; 09/25/2024
• 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: Hospitalization; Other
• Patient Sex: Unknown