BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 4956169 · Received July 31, 2015

    Report

    Report Number
    9612501-2015-00451
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 24, 2015
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTROSTOMY. ACCORDING TO THE REPORTER: THE SURGEON USED 2-0 SILK WITH THE ENDOSTITCH INSTRUMENT FOR GASTROSTOMY CLOSURE. NEEDLE BROKE IN THE PATIENT. IT DELAYED THE CASE BY 1 HOUR DUE TO REQUIRING C-ARM TO LOCATE THE COMPONENTS OF BROKEN NEEDLE. THEY WERE ABLE TO RETRIEVE THE NEEDLE. SURGERY TIME WAS DELAYED BY MORE THAN 30 MINUTES. THE SURGEON WAS AN EXPERIENCED USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499331 ENDO STITCH* 10MM SUTURING DEVICE SINGLE USE SUTURING DEVICE KOG COVIDIEN 173016

    Patients

    Seq Age Sex Outcome Treatment
    1 Other