BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA TDS 1.14 GROMMET

    MDR report key: 18114903 · Received November 10, 2023

    Report

    Report Number
    3012130335-2023-00002
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    November 22, 2022
    Report Date
    November 10, 2023
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600047
    PMA / PMN Number
    P190016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194511 TULA TDS 1.14 GROMMET TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. 21110101 00840128600047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown