BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM-400

    MDR report key: 6261009 · Received January 18, 2017

    Report

    Report Number
    9614750-2017-00003
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    March 14, 2016
    Report Date
    January 18, 2017
    Manufacturer
    ITO CO., LTD. TSUKUBA FACTORY
    Product Code
    ITH
    PMA / PMN Number
    K081247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS DISCARDED AT THE EVENT SITE. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ITO EXAMINED THE DEVICE HISTORY RECORD FOR THE SUBJECT TM-400 DEVICE. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. THE USER FACILITY DID NOT DISCLOSE THE PATIENT'S INFORMATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE TRACTION ROPE OF THE SUBJECT TM-400 DEVICE GOT STUCK. EVEN AFTER WAITING A WHILE TO TRY TO PULL OUT THE ROPE, THE ROPE WAS STILL STUCK AND COULD NOT BE PULLED OUT. AFTER TURNING OFF THE POWER AND TRYING TO RESUME THE PROCEDURE, THE ROPE COULD BE REELED UP AND A SMOOTH TRACTION WAS RESUMED. WHEN THE TRACTION POWER LEVEL WAS SET FROM 0 TO 60%, THE ROPE GOT STUCK INSTANTANEOUSLY AND THEN STARTED TRACTION WITH A HIGH SPEED (A SPEED OF 60 TO 100% TRACTION POWER). WHEN THE 90KG SETTING WAS SELECTED, THE ROPE BECAME STUCK WITHOUT EXCEPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43399 TM-400 EQUIPMENT, TRACTION, POWERED ITH ITO CO., LTD. TSUKUBA FACTORY TM-400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other