BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 6188709 · Received December 20, 2016

    Report

    Report Number
    6188709
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 30, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO ENDOSTITCH DEVICES WERE USED DURING SURGICAL PROCEDURE - PATIENT INFORMATION NOT PROVIDED, UNAWARE OF SURGICAL PROCEDURE DURING CASE. FIRST ENDO STITCH WAS UNABLE TO LOAD, NEEDLE WAS UNABLE TO BE ENGAGED IN THE DEVICE AND BECAME STUCK IN THE DEVICE. THE 2ND ENDOSTITCH NEEDLE UNABLE TO ENGAGE IN DEVICE. BOTH WITH THE SAME LOT 3 ON EACH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839352 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN J6F0073X

    Patients

    Seq Age Sex Outcome Treatment
    1