BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6770292

    MDR report key: 6770292 · Received August 7, 2017

    Report

    Report Number
    6770292
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 28, 2017
    Report Date
    August 2, 2017
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TI KNOT DEVICE WOULD NOT CUT THE SUTURE PROPERLY. A SECOND TI-KNOT DEVICE WAS OPENED AND WORKED AS EXPECTED. MANUFACTURER RESPONSE FOR DISPOSABLE 5MM TITANIUM KNOT PLACEMENT DEVICE, LSI SOLUTIONS (PER SITE REPORTER): MANUFACTURER PROVIDED COMPLAINT# TO TRACK THE PRODUCT EVALUATION.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR