BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1033051 · Received April 22, 2008

    Report

    Report Number
    1219930-2008-00314
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    December 21, 2007
    Report Date
    March 25, 2008
    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

    INITIAL REPORT SENT: 4/22/08. IT WAS FOUND, DURING THE EVAL OF THE PRODUCT, THAT THE JAWS WERE SLIGHTLY MISALIGNED, WHICH CONTRIBUTED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE JAWS WERE STICKING AND THE NEEDLE BENT AND DISENGAGED AS IT WAS BEING PASSED THROUGH TISSUE. THE NEEDLE WAS RETRIEVED AND THERE WAS NO DELAY IN THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N7L292

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK