BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH POLYSORB 2/0 48 VIO DLU SU

    MDR report key: 2182017 · Received June 22, 2011

    Report

    Report Number
    1219930-2011-00509
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 22, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING PREPARATION FOR SURGERY, IT WAS NOTICED THE NEEDLE HAD COME OFF OF THE CARTRIDGE. THE DEVICE WAS NOT USED FOR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH POLYSORB 2/0 48 VIO DLU SU DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N9C1011

    Patients

    Seq Age Sex Outcome Treatment
    1