BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3851135 · Received March 21, 2014

    Report

    Report Number
    1219930-2014-00223
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    November 6, 2013
    Report Date
    February 24, 2014
    Manufacturer
    COVIDIEN, FORMELRY US
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE ENDOSTITCH WOULD NOT HOLD THE NEEDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FORM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170253 ENDO STITCH 10MM SUTURING DEVICE DISPSOABLE SUTURING DEVICE KOG COVIDIEN, FORMELRY US N3C0612X

    Patients

    Seq Age Sex Outcome Treatment
    1