BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 2202369 · Received August 3, 2011

    Report

    Report Number
    1219930-2011-00610
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 30, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC NISSEN FUNDOPLICATION AND REPAIR OF A HIATUS HERNIA. ACCORDING TO THE REPORTER: DURING THE SUTURING, THE ENDOSCOPIC NEEDLE BROKE OFF FROM THE DEVICE. AN ABDOMINAL FILM DID NOT REVEAL THE NEEDLE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other ENDO STITCH SOFSILK SOFSILK 0 48 BLACK DLU SU| CATALOG # 170003, K934738