BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5142204

    MDR report key: 5142204 · Received October 9, 2015

    Report

    Report Number
    5142204
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    May 17, 2015
    Report Date
    September 18, 2015
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CLIPS WOULD NOT LOAD PROPERLY. THIS WAS NOTICED TWICE IN THE SAME PROCEDURE. A DIFFERENT CLIP APPLIER WITH A DIFFERENT LOT NUMBER WAS OBTAINED AND WORKED CORRECTLY. IT WAS ALSO NOTED THAT THE SAME DEVICE WITH THE TROUBLING LOT NUMBER WAS USED IN ANOTHER PROCEDURE THAT SAME DAY AND PERFORMED FINE.

    Patients

    Seq Age Sex Outcome Treatment
    1