BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10 MM SUTURING DEVICE

    MDR report key: 1901077 · Received November 10, 2010

    Report

    Report Number
    1219930-2010-00851
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    May 25, 2010
    Report Date
    October 13, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BAND. ACCORDING TO THE REPORTER: WHEN APPLYING NEEDLE TO TISSUE TO PLACE STITCH THE HEAD OF THE INSTRUMENT TWISTED AND BROKE AND WOULD NOT TOGGLE. THERE WAS NO EXTRA BLOOD LOSS AND THE TIME WAS NOT INCREASED BY MORE THAN 10 MINUTES. PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10 MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N0B0133

    Patients

    Seq Age Sex Outcome Treatment
    1