BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1973834 · Received January 20, 2011

    Report

    Report Number
    1219930-2011-00043
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 23, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. ACCORDING TO THE REPORTER: THE NEEDLE ON THE SUTURE BROKE. HALF OF THE NEEDLE WAS RETRIEVED AND THE HALF WAS RETAINED IN THE PT'S STOMACH. THIS WAS REPORTED TO THE FDA. USED ANOTHER DEVICE TO FINISH THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other