BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 3082881 · Received April 22, 2013

    Report

    Report Number
    1219930-2013-00304
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUNG RESECTION. ACCORDING TO THE REPORTER: THE BLACK RETURN KNOB WOULD NOT RETRACT AFTER 1ST FIRING ON THE MARGINAL REGION OF THE LUNG. THE SURGEON FORCIBLY REMOVED THE DEVICE AND PERFORMED AN ADDITIONAL RESECTION WITH A NEW CARTRIDGE WITHOUT EXTENDING THE INCISION. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NOTHING FELL INTO PT'S CAVITY. THERE WAS TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. THE LOT NUMBER WAS NOT IDENTIFIED. THE SALES REP RECEIVED THE CLINICAL SAMPLE AND FOUND THE ANVIL WAS CURVED, AND A SCRUB NURSE COMMENTED THAT THE TISSUE WAS QUITE THICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172073 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 030449, LOT #NOT AVAILABLE, #K061095| ENDO GIA UNIVERSAL 12MM SINGLE USE INST: