BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6045321 · Received October 20, 2016

    Report

    Report Number
    9612501-2016-00820
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    August 5, 2016
    Report Date
    September 26, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ESOPHAGOGASTRECTOMY FOR A FEEDING TUBE PLACEMENT, THE STICH CAME OF THE DEVICE 3 TIMES. TO CORRECT THE CONDITION ANOTHER DEVICE AND SUTURE OF THE SAME KIND WERE USED SUCCESSFULLY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT DEVELOPED POSTOPERATIVE DYSPHAGIA WHICH REQUIRED A DILATION PROCEDURE WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694064 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6E2470X

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention