BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3896794 · Received June 9, 2014

    Report

    Report Number
    9612501-2014-00183
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 19, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ESOPHAGUS. ACCORDING TO THE RPTR: THE "SURGIDAC" ENDOSTITCH SUTURE NEEDLE DID NOT CONNECT WITH ENDOSTITCH SUTURING DEVICE AND WAS RETAINED IN THE PARA-ESOPHAGEAL TISSUE. THE SURGEON WAS UNABLE TO RETRIEVE IT OUT OF THE TISSUE DUE TO THE SMALL SIZE OF THE NEEDLE. ADD'L INFO HAS BEEN REQUESTED FROM THE SITE. SEE ALSO MEDWATCH # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336311 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other