BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1372668 · Received February 19, 2009

    Report

    Report Number
    1219930-2009-00114
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    January 28, 2009
    Report Date
    January 28, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BANDING. ACCORDING TO THE REPORTER: NEEDLE BROKE WHEN TOGGLING, A PIECE WAS REMOVED FROM THE PATIENT TISSUE AND OTHER PIECE WAS STUCK IN THE DEVICE. SURGERY TIME WAS EXTENDED 10 MINUTES. IT IS NOT KNOW WHAT WAS DONE TO FINISH THE CASE. NO BLOOD LOSS REPORTED AND NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N8L97

    Patients

    Seq Age Sex Outcome Treatment
    1