BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND

    MDR report key: 11853799 · Received May 20, 2021

    Report

    Report Number
    3016677053-2021-00001
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 24, 2021
    Report Date
    May 20, 2021
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    PMA / PMN Number
    DEN190020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE REPORTED DESCRIPTION, THE IFU WAS NOT FOLLOWED AND A USER ERROR OCCURRED WHEN THE SUTURE WAS RELEASED PRIOR TO THE POSITIONING OF THE ITIND. THE REMOVAL OF THE ITIND WAS UNSUCCESSFUL PROBABLY DUE TO THE INEXPERIENCE OF THE DOCTOR (SECOND PROCEDURE) AND THE FACT THAT HE DIDN'T AGREE TO USE THE CYSTOSCOPE OPTICS, THUS TRYING TO PULL THE DEVICE INTO THE CYSTOSCOPE BLINDLY. HE THEN DECIDED TO SWITCH TO A TURP PROCEDURE, AT THE END OF WHICH REMOVAL AS PER ITIND IFU WAS PERFORMED (GRASPER). THE DECISION OF THE DOCTOR TO SWITCH TO A TURP FOR TREATMENT OF THE BPH RESULTED IN HOSPITALIZATION NOT PLANNED AS THE ITIND PROCEDURE DOES NOT REQUIRE THE PATIENT TO BE HOSPITALIZED, BUT A TURP, AS STANDARD, DOES. HOWEVER, THIS CANNOT BE ATTRIBUTED TO THE ITIND ITSELF. ALTHOUGH THE DEVICE DID NOT MALFUNCTION AND THERE WAS NO INJURY TO THE PATIENT, A SURGICAL INTERVENTION WAS NECESSARY TO PERFORM THE REMOVAL OF THE ITIND AS OUTLINED IN THE IFU AND TO AVOID A POTENTIAL INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2021 2 PROCEDURES WERE PERFORMED AT (B)(6) HOSPITAL, (B)(6). THE FIRST ONE HELD AT 08:45 IN THE MORNING WENT ON WITHOUT ANY PROBLEMS OR COMPLICATIONS. IN THE SECOND PROCEDURE, AFTER THE PASSAGE OF THE ITIND DEVICE INSIDE THE CYSTOSCOPY SHIRT, BY MISTAKE IN THE STEPS OF THE PROCEDURE, THE ITIND SUTURE WAS ACCIDENTALLY PULLED AND IT WAS RELEASED FROM ITS TUBE GUIDE, THIS STEP SHOULD BE DONE ONLY AFTER THE FINAL POSITIONING OF THE ITIND IN THE PROSTATE, BECAUSE AFTER LOOSENING THE SUTURE, THE DEVICE'S MANEUVERABILITY CONTROL IS LOST. THEREFORE, IT WAS RECOMMENDED THAT THE TEAM REMOVE THE DEVICE TO APPLY ANOTHER UNIT. WHEN PERFORMING THE REMOVAL USING THE CYSTOSCOPY SHEET, THE SUTURE BROKE FROM THE ITIND AND IT WAS RELEASED INSIDE THE PATIENT'S BLADDER. TO REMOVE THE DEVICE, IT WAS NECESSARY TO INTRODUCE A 24 FR SHEET FOR PROSTATE RESECTION, THE PROCEDURE WAS CONVERTED TO A MONOPOLAR PROSTATE TRP (TRANSURETHRAL RESECTION OF THE PROSTATE). WHERE THE OBSTRUCTIVE TISSUE WAS REMOVED, AND WITH BETTER FLOW AND BETTER VISUALIZATION, THE ITIND DEVICE WAS COMPLETELY REMOVED WITH THE AID OF AN OPTICAL GRASPING FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752930 ITIND ITIND SYSTEM QKA MEDI-TATE LTD. MT-FA04 U1S14062020-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention