BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6180473

    MDR report key: 6180473 · Received December 16, 2016

    Report

    Report Number
    6180473
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    September 13, 2016
    Report Date
    December 15, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ECHELON 60 POWERED STAPLER (PSEE60A) ECHELON FLEX POWERED PLUS STAPLER COMPLETELY MALFUNCTIONED ONCE CLAMPED TO THE TISSUE. THE STAPLER WOULD NOT FIRE NOR RELEASE THE TISSUE. THIS MALFUNCTION CAUSED A BLOOD LOSS OF 200CC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other