BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR* 45-2.0 SULU

    MDR report key: 4120971 · Received September 26, 2014

    Report

    Report Number
    1219930-2014-00885
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAG
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SEGMENTECTOMY. ACCORDING TO THE REPORTER: THE RELOAD WAS FIRED ACROSS THE PULMONARY ARTERY. THE BLACK HANDLES WERE PULLED BACK TOO EASILY DURING THE PROCEDURE AND THE BLADE WAS NOT RETRACTED WHEN THE HANDLES WERE PULLED BACK. THE RELOAD WOULD NOT OPEN. DR. (B)(6) HAD PROXIMAL CONTROL OF THE PA, SO DR. (B)(6) ASSISTED IN CUTTING THE RELOAD OFF OF THE TISSUE. DR. (B)(6) INSPECTED THE SPECIMEN ON THE BACK TABLE AND NOTICED THE STAPLE LINE WAS FORMED, BUT THE BLADE DID NOT RETRACT. THERE WAS A SMALL AMOUNT OF TISSUE LOSS AS THE TISSUE WAS TRANSECTED. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES AND NO DEVICE FRAGMENT FELL IN THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601566 ENDO GIA ROTICULATOR* 45-2.0 SULU DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON 030453 N3J1693LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other