BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTITCH

    MDR report key: 4992981 · Received August 4, 2015

    Report

    Report Number
    MW5055266
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    May 15, 2015
    Report Date
    August 4, 2015
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    WHILE SUTURING THE VAGINAL CUFF USING A 0 VICRYL ENDOSTITCH AND THE 10MM ENDOSTITCHER, THE NEEDLE BROKE IN HALF - LEAVING HALF OF THE NEEDLE STUCK IN THE ENDOSTITCHER AND THE OTHER HALF IN THE PATIENT'S TISSUE A TOTAL OF 3 X-RAYS WERE TAKEN: 1ST X-RAY VERIFIED FOREIGN BODY; 2ND X-RAY VERIFIED LOCATION OF FOREIGN BODY NEAR AN ENDOCLIP PLACED INTRAOP; MULTIPLE ATTEMPTS TO RETRIEVE WITH NO SUCCESS; 3RD X-RAY SHOWS ENDOCLIP REMOVED AND FOREIGN BODY STILL PRESENT. RISK BENEFIT ANALYSIS DONE AND DECISION MADE TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511789 ENDOSTITCH ENDOSTITCH OCW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR