BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 4041021 · Received August 6, 2014

    Report

    Report Number
    1219930-2014-00613
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DURING LAR SURGERY, THE SULU FAILED TO CLOSE TO GRASPED RECTAL TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459715 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE SURGICAL STAPLER GDW COVIDIEN N9F0098

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR