BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGON TONGUE SUTURE PASSER

    MDR report key: 10777406 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-01720
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    February 10, 2020
    Report Date
    February 10, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    01081867402220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS AND PRECAUTIONS MENTIONED IN THE IFU254BSM THAT WERE NOT FOLLOWED. IT WAS A MISUSE BY PHISICIAN. WE ASSUME THAT WRONG USE AND NOT FOLLOWING THE IFU INSTRUCTIONS IS THE REASON FOR THIS FAILURE

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE NEW DRAGON TONGUE CAPSULAR CLOSURE DEVICE. WHEN THE SURGEON WENT TO SLIDE THE BLUE LEVER ON THE HANDLE, THE PEEK TUBING WAS DISPLACED FROM THE PLASTIC PART, WHERE IT IS ENGAGED, OF THE HANDLE. THE DEVICE WAS REMOVED FROM THE PATIENT SAFELY LEAVING NO REMAINING PIECES IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241067 DRAGON TONGUE SUTURE PASSER DRAGON TONGUE SUTURE PASSER MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 11003984 19N05 01081867402220

    Patients

    Seq Age Sex Outcome Treatment
    1