TULA TDS114GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840128600047), received between Sep 10, 2021 and Sep 26, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, WHILE TUBE PLACEMENT; THE SURGEON REPORTED A TUBE MEDIALIZATION WITH THE SECOND TDS DEVICE. THE SURGEON REPORTED HE WAS ABLE TO SUCCESSFULLY PLACE A BACK UP DEVICE IN THE TYMPANIC MEMBRANE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307244 ↗
• InjuryNov 10, 2023Activation Problem; Activation Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18114903 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410474 ↗
• InjuryNov 5, 2022Unintended System Motion; Material Protrusion/Extrusion; Unintended System Motion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT TWO WEEKS AFTER A TYMPANOSTOMY PROCEDURE USING A TULA DEVICE, AT THE PATIENT FOLLOW UP IT WAS NOTICED THAT PATIENT EXPERIENCED AN EARLY TUBE EXTRUSION. PATIENT EAR HAD ACTIVE INFECTION. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 15740866 ↗
• MalfunctionSep 10, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN OFFICE-BASED ENT PROCEDURE, A TYMPANOSTOMY TUBE PLACED BY THE TULA TUBE DELIVERY SYSTEM WAS MEDIALIZED INTO THE MIDDLE EAR UPON ACTUATION OF THE DEVICE. THE ENT SURGEON STATED THAT DURING DEPLOYMENT, THE PATIENT WAS MOVING, AND SURGEON HAD POOR VISUALIZATION, AND MAYBE OVERCOMPENSATED WITH PRESSURE ON THE DRUM. THE ENT SURGEON STATED THAT THE EAR CANAL LOOKED SMALLER AND THAT THE CHILD WAS FEISTY BUT NOTHING UNUSUAL WAS NOTICED ABOUT THE TISSUE IN THE TARGET LOCATION, TUBE OR THE DEVICE. A DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED WHILE THE SURGEON ATTEMPTED TO RETRIEVE THE MEDIALIZED TUBE, WHICH ULTIMATELY WAS NOT SUCCESSFUL. A NON-SMITH & NEPHEW TYMPANOSTOMY TUBE (SILICONE ARMSTRONG GROMMET) WAS PLACED USING TRADITIONAL TECHNIQUES, AND THE TULA TYMPANOSTOMY TUBE WAS LEFT RETAINED IN THE MIDDLE EAR CAVITY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT IS DOING WELL, AND STANDARD POST-SURGICAL FOLLOW-UPS ARE PLANNED. THE SURGEON WILL FOLLOW GUIDELINES THAT SUGGEST TUBE MAY BE LEFT IN THE MIDDLE EAR AND WILL EXPLANT IF CHILD NEEDS ANOTHER TUBE SURGERY IN WHICH CASE AN OR PROCEDURE WILL BE RECOMMENDED UNDER GENERAL ANESTHESIA FOR TH

  Patient problems: Foreign Body In Patient

  MAUDE report 12456624 ↗