BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* SURGIDAC* 2/0 7 GRN DLU SU

    MDR report key: 4827384 · Received June 9, 2015

    Report

    Report Number
    9612501-2015-00302
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Report Date
    June 1, 2015
    Manufacturer
    COVIDIEN
    Product Code
    ---
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS ACCORDING TO THE REPORTER: ENDOSTITCH SURGIDAC USED (173021) DURING CREATION OF THE GASTROJEJUNOSTOMY ENDOSTITCH SUTURE DETACHED FROM THE NEEDLE, LEADING THE NEEDLE SECURED INSIDE THE JAWS OF THE ENDOSTITCH DEVICE. NOTHING FELL INTO THE PATIENT'S CAVITY. THE NEEDLE BROKE WHILE HOLDING TENSION ON RUNNING A SUTURE LINE. IT BROKE BETWEEN THE NEEDLE AND THE FERRULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370386 ENDO STITCH* SURGIDAC* 2/0 7 GRN DLU SU SINGLE USE SUTURING DEVICE --- COVIDIEN 173021 J4H1062X

    Patients

    Seq Age Sex Outcome Treatment
    1