BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1377729 · Received March 9, 2009

    Report

    Report Number
    1219930-2009-00155
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 26, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THIS DEVICE WAS USED TO OVER-SEW A LINEAR STAPLE LINE. THE TECH HAD BEEN HAVING PROBLEMS LOADING THE INSTRUMENT AND DURING USE BY THE SURGEON THE NEEDLES KEPT PULLING OUT OF THE HANDLE. REPORTEDLY, THE INSTRUMENT WAS NOT RETURNED TO NEUTRAL POSITION (BOTH JAWS CLOSED), WHEN PLACING TENSION OF THE SUTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1