BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1346730 · Received March 18, 2009

    Report

    Report Number
    1219930-2009-00190
    Event Type
    Injury
    Date Received
    March 18, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 4, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAP NISSEN. ACCORDING TO THE RPTR: PT'S STOMACH TISSUE WAS CATCHING ON THE NEEDLE, THE NEEDLE THEN TORE THE TISSUE. DOCTOR HAD TO OVER SEW THE AREA. THERE WAS LITTLE BLOOD LOSS REPORTED. SURGERY TIME WAS EXTENDED LESS THAN 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N9A386

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R