BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 8702620 · Received June 16, 2019

    Report

    Report Number
    1219930-2019-03511
    Event Type
    Malfunction
    Date Received
    June 16, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 16, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543782
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE HANDLE WAS ABLE TO RECOGNIZE THE TWO RELOADS AND STAPLER WAS ABLE TO FIRE BUT DEVICE STOPPED DISTALLY. IT WAS STATED THAT THERE WAS AN INCOMPLETE STAPLE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496117 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGPHANDLE 10884521543782

    Patients

    Seq Age Sex Outcome Treatment
    1