BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-4.8 SULU

    MDR report key: 1915750 · Received November 29, 2010

    Report

    Report Number
    1219930-2010-00895
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 19, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4) . INITIAL REPORT SENT TO FDA ON (B)(6) 2010.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE INSTRUMENT CUT BUT DID NOT STAPLE. THIS RESULTED IN ADDITIONAL TISSUE RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-4.8 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N9L0301

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability