BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ADAPTER STANDARD

    MDR report key: 3969299 · Received May 2, 2014

    Report

    Report Number
    1219930-2014-00346
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 10, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AFTER SETTING WITH IDRIVE, A DOCTOR FOUND THE UNCONTROLLABLE ARTICULATION OF THE SULU. IT WAS NOT USED FOR PROCEDURE. NO PATIENT INVOLVEMENT. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265286 ENDO GIA ADAPTER STANDARD REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1