BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5821762

    MDR report key: 5821762 · Received July 26, 2016

    Report

    Report Number
    5821762
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 13, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEM-O-LOK CLIPS CONSISTENTLY FELL OFF THE APPLIER DURING A PROCEDURE. THE SURGEON HAD TO SPEND TIME RETRIEVING THE CLIPS THAT FELL OUT INTO THE SURGICAL SPACE. ALL OF THE CLIPS WERE RETRIEVED. HOWEVER THERE WAS A SLIGHT DELAY IN THE CASE.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR THE CLIP APPLIER WAS NOT SAVED OR DOCUMENTED. WE A