BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD REVOLUTION

    MDR report key: 6940807 · Received October 11, 2017

    Report

    Report Number
    3006680097-2017-00001
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    August 26, 2017
    Report Date
    October 11, 2017
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K141657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THD SYSTEM INVOLVED IN THE EVENT IS BASED ON THE DOPPLER-GUIDED LOCATION AND LIGATION OF THE TERMINAL BRANCHES OF THE SUPERIOR HAEMORRHOIDAL ARTERY USING THE THD EVOLUTION OR THD REVOLUTION DEVICES AND THEIR COMPATIBLE SINGLE-USE KITS. THEN, THD EVOLUTION AND THD REVOLUTION DEVICES ARE USED IN CONJUNCTION WITH DEDICATED INSTRUMENTS, SUCH AS THD KIT, THD FIBER OPTIC CABLE AND THD DOPPLER PROBE. IN PARTICULAR, IN THE THD SYSTEM, THE FIBER OPTIC CABLE IS CONNECTED TO THE THD EVOLUTION AND THD REVOLUTION DEVICES AND, BY COUPLING THE TIP ON THE HANDLE OF THE THD SLIDE PROCTOSCOPE, IT ACTS AS AN ILLUMINATOR OF THE OPERATING FIELD. WE HAVE CONSIDERED AS OBJECT OF THIS REPORT THE ONLY DEVICE PART OF THE SYSTEM NOT DISPOSED BY THE FACILITY AT THE END OF THE TREATMENT (THD REVOLUTION).

    Description of Event or Problem · 1

    AT THE END OF THE PROCEDURE, THE SURGEON FOUND A SUPERFICIAL BURNT ON THE PATIENT SKIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT BURN WOUND WAS DRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719060 THD REVOLUTION THD REVOLUTION JAF THD SPA 800133 00002514

    Patients

    Seq Age Sex Outcome Treatment
    1