BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN HEMORRHOID AND PROLAPSE STAPLER

    MDR report key: 7244384 · Received February 5, 2018

    Report

    Report Number
    MW5075068
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 2, 2018
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE COVIDIEN EEA HEMORRHOID AND PROLAPSE STAPLER WITH DST SERIES TECHNOLOGY DID NOT COMPLETELY STAPLE WHEN DISCHARGED BY THE SURGEON. PER THE SURGEON, DURING FIRST ATTEMPT THE STAPLER MISFIRED LEAVING THE STAPLE LINE LOOSE. DURING SECOND ATTEMPT, IT MADE A SNAPPING NOISE, THE STAPLER HOUSING BROKE AFTER FIRING WHICH LEFT THE STAPLE LINE LOOSE. THE ISSUE WAS REPORTED TO REGIONAL RISK MANAGEMENT AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86627 COVIDIEN HEMORRHOID AND PROLAPSE STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN HEM3335 N7J0281MX

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR