BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILS STITCH SUTURING DEVICE

    MDR report key: 3964138 · Received May 22, 2014

    Report

    Report Number
    1219930-2014-00398
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP NISSEN. ACCORDING TO THE REPORTER: THE INSTRUMENT DIDN'T GRIP THE NEEDLE PROPERLY AS THE OTHER LEG OF THE INSTRUMENT REMAINED EXTENDED. WHEN THE DOCTOR TRIED TO SWITCH THE NEEDLE, THE NEEDLE FELL OUT OF THE JAWS. THERE WAS NO LOSS OF BLOOD BUT THE PROCEDURE TIME WAS EXTENDED BY 15 MINUTES. THE DOCTOR USED THE CORRECT TECHNIQUE TO LOAD THE INSTRUMENT. THIS COMPLAINT IS RELATED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306848 SILS STITCH SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN, FORMERLY US N3F0424X

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR