BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE RIGHT ANGLE LINEAR CUTTER SULU

    MDR report key: 2100049 · Received May 16, 2011

    Report

    Report Number
    1219930-2011-00390
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K102325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOWER ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE DEVICE WOULD NOT FIRE ACROSS COLON. NO BLEEDING IN EXCESS OF 250CC WAS REPORTED. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDRIVE RIGHT ANGLE LINEAR CUTTER SULU SURGICAL STAPLER GDW UNITED STATES SURGICAL L1B01UX

    Patients

    Seq Age Sex Outcome Treatment
    1