BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 2522237 · Received April 3, 2012

    Report

    Report Number
    1219930-2012-00309
    Event Type
    Injury
    Date Received
    April 3, 2012
    Report Date
    March 26, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UNK. ACCORDING TO REPORTER: DURING THE FIRING, THE PT¿S TISSUE TORE. THE CHARGE WAS FIRED AS A WHOLE AND THE STAPLES WERE CLOSED; STAPLE FORMATION WAS SUCCESSFUL. THE SURGEON HAD TO SPEND POINTS WITH MANUAL SUTURE REINFORCEMENT AND THE REMAINING TISSUE WAS STAPLED WITH A COMPETITOR¿S PRODUCT. THERE WAS NO SIGNIFICANT BLEEDING: THE SURGERY TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES DUE TO THIS PROBLEM. THERE WAS A LOSS OF SOME TISSUE, BECAUSE IN ORDER TO REMOVE THE STAPLER, THE SURGEON HAD TO PULL THE PULMONARY PARENCHYMA RESULTING IN TEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N0B0524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other