BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1376514 · Received March 4, 2009

    Report

    Report Number
    1219930-2009-00154
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    February 11, 2009
    Report Date
    February 11, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE PRODUCT COULD NOT BE EASILY LOADED. IT SEEMED AS THOUGH THE NEEDLE WAS NOT LOADED IN THE PROPER POSITION. IN ADDITION, WHEN THE PRODUCT WAS LOADED, NEEDLE DETACHED FROM THE DEVICE DURING PASSAGE THROUGH TISSUE. NO PT INJURY WAS REPORTED. PT IS IN WELL CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N8M230

    Patients

    Seq Age Sex Outcome Treatment
    1 BLCK DLU.| PRODUCT ID: 170004