BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFIT TTFM PROBES PQ PROBE 3MM

    MDR report key: 5842715 · Received August 3, 2016

    Report

    Report Number
    5842715
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 22, 2016
    Manufacturer
    MEDISTIM ASA
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ANASTOMOSIS PROBE WAS SUCCESSFULLY USED TO TEST 2 VESSELS DURING SURGERY. WHEN ATTEMPTING TO USE THE PROBE ON A THIRD VESSEL IT FAILED. IT DID NOT READ A VALUE WHEN ACTIVATED TO TELL YOU HOW MUCH FLOW IS RUNNING THROUGH THE VESSEL. WHEN THE PROBE FAILED, A NEW (SECOND) PROBE WAS OBTAINED AND OPENED. THE REPLACEMENT PROBE WORKED. THE DELAY TO THE PATIENT WAS A FEW MINUTES TO OBTAIN THE NEW PROBE AND OPEN IT TO THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495573 QUICKFIT TTFM PROBES PQ PROBE 3MM TRANSDUCER, ULTRASONIC ITX MEDISTIM ASA 70153

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR