BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1822009 · Received April 6, 2010

    Report

    Report Number
    1219930-2010-00271
    Event Type
    Injury
    Date Received
    April 6, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 9, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: NISSEN. ACCORDING TO THE REPORTER: THE SUTURES ARE PULLING OFF THE NEEDLES; THE NEEDLE COULD NOT BE RETRIEVED. AN X-RAY WAS TAKEN VERIFYING THAT THE NEEDLE WAS IN THE PATIENT. SURGEON DETERMINED IT WOULD BE UNSAFE TO ATTEMPT TO RETRIEVE THE NEEDLE FROM THE PATIENT'S TISSUE. THERE WAS NO REPORT OF PATIENT INJURY, UNANTICIPATED BLOOD OR TISSUE LOSS, OR EXTENDED OPERATING ROOM TIME. AN X-RAY WAS TAKEN VERIFYING THAT THE NEEDLE WAS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N9L0554

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other ENDO STITCH SOFSILK 2/0 48 BLCK DLU SU, 170004,| LOT #: N9K0655