BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 2990257 · Received February 7, 2013

    Report

    Report Number
    1219930-2013-00056
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: SUTURE WOULD NOT FUNCTION. THERE WAS NO UNANTICIPATED TISSUE LOSS OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52229 ENDO STITCH* 10MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL N2F0089X

    Patients

    Seq Age Sex Outcome Treatment
    1