BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILTOP

    MDR report key: 1810138 · Received August 17, 2010

    Report

    Report Number
    2647580-2010-00710
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 12, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE HEAD WAS INTRODUCED LIKE USUALLY AND THE STAPLER WAS INTRODUCED RECTAL AND THEN TURNED TOGETHER. THE SURGEON FIRED THE INSTRUMENT AFTER FOUR AND HALF TURNS TO CLOSE THE INSTRUMENT. THE INSTRUMENT WITH THE PRESSURE PLATE COULD NOT BE REMOVED FROM THE PATIENT. IT WAS CONTROLLED ENDOSCOPICALLY DURING THE OP AND THE INSTRUMENT CLAMPED BUT DID NOT CUT. THE COMPLETE ANASTOMOSIS WAS DISSECTED AND A NEW ANASTOMOSIS WAS MADE. OPERATING ROOM TIME WAS EXTENDED BY MORE THAN 30 MINUTES. UNANTICIPATED LOSS TO VASCULAR TISSUE OCCURRED. NO ADDITIONAL BLOOD LOSS, NO EXTENSION OF THE INCISION, AND NO CHANGE OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILTOP DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P9J0983J

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| S