BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6161332

    MDR report key: 6161332 · Received December 9, 2016

    Report

    Report Number
    6161332
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 28, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAPLES DID NOT FIRE WHEN ACTIVATED. THE DEVICE WAS PASSED OFF THE FIELD AND A NEW PRODUCT WAS USED. THERE WAS NO HARM TO THE PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR