BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7077489 · Received December 1, 2017

    Report

    Report Number
    1219930-2017-09213
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    August 30, 2017
    Report Date
    December 1, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K133938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 LUNG RESECTION (OPEN PROCEDURE), THE DEVICE HAD POOR STAPLE FORMATION. ONE SIDE OF THE STAPLE LINE WAS INCOMPLETE. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THE EVENT. SURGEON OVER SEWED THE STAPLE LINE IN ORDER TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855029 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIATRS60AMT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1