BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1933417 · Received December 3, 2010

    Report

    Report Number
    1219930-2010-00912
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 4, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE NEEDLE BROKE IN HALF WHILE IN USE AND BECAME STUCK IN THE TIP OF THE ABDOMEN. THE RETAINED PIECE WAS RETRIEVED AND BOTH PIECES WERE COMPARED TO AN INTACT NEEDLE. IT APPEARED AS IF BOTH PIECES EQUALED THE SIZE OF AN INTACT NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE NONE KOG UNITED STATES SURGICAL N0F0379

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR