BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8013601

    MDR report key: 8013601 · Received October 29, 2018

    Report

    Report Number
    8013601
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 18, 2018
    Report Date
    October 23, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON INSERTION OF THE ANVIL OF THE INTRALUMINAL EEA STAPLER, THE BREAKAWAY WASHER CAME LOOSE AND FELL INTO THE PATIENT'S ABDOMEN. THE PIECE WAS ABLE TO BE RETRIEVED WITH OUT ISSUE. THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR EEA STAPLER, (BRAND NOT PROVIDED) (PER SITE REPORTER). THE MANUFACTURER REP WAS IN THE OPERATING ROOM WHEN THE EVENT OCCURRED.

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA