BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU

    MDR report key: 2030763 · Received March 22, 2011

    Report

    Report Number
    1219930-2011-00218
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 21, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: NISSEN. ACCORDING TO THE REPORTER: THE THREAD WAS DETACHED FROM THE NEEDLE DURING THE PROCEDURE. OPERATING ROOM TIME WAS NOT EXTENDED LONGER THAN 30 MINS, THERE WAS NO ADDITIONAL BLOOD LOSS OR TISSUE DAMAGE, NOTHING FELL INTO THE PT'S CAVITY, AND THE PT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL A7J766

    Patients

    Seq Age Sex Outcome Treatment
    1