BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 2112222 · Received April 29, 2011

    Report

    Report Number
    1219930-2011-00346
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BANDING. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, TWO INSTRUMENTS FAILED TO LOAD CORRECTLY. ONE INSTRUMENT WOULD NOT HOLD THE NEEDLE (AS DESCRIBED IT KEPT FALLING OUT AFTER MULTIPLE ATTEMPTS TO LOAD DIFFERENT NEEDLES) AND SO THEY OPENED A SECOND DEVICE. THE SECOND DEVICE LOADED CORRECTLY, BUT DURING THE CYCLING OF THE INSTRUMENT TO ENSURE THE NEEDLE WAS LOADED CORRECTLY, THE NEEDLE WAS CUT IN HALF WHEN TOGGLED. BOTH HANDLES WERE DISCARDED FROM THE FIELD AND A THIRD HANDLE WAS OPENED. THE THIRD HANDLE WAS LOADED AND PERFORMED APPROPRIATELY. NEITHER OF THE TWO NON-FUNCTIONING HANDLES WERE USED ON THE PATIENT AND THUS NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N1A0162

    Patients

    Seq Age Sex Outcome Treatment
    1