BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM

    MDR report key: 8386101 · Received March 1, 2019

    Report

    Report Number
    MW5084579
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 22, 2019
    Report Date
    February 28, 2019
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ENDO STITCH 10MM WAS BEING USED AS PART OF PROCEDURE. WHEN THE SURGICAL TECH ATTEMPTED TO REMOVE THE SUTURE OFF OF THE ENDO STITCH, THE SUTURE NEEDLE BROKE IN 2 PIECES, (1 PIECE WAS STUCK ON THE ENDO STITCH) IT NEVER REACHED THE PATIENT. SURGEON WAS AWARE OF SITUATION AND WAS ABLE TO FREE THE NEEDLE FROM THE ENDO STITCH. NOW 2 PIECES (EQUIVALENT OF 1 SUTURE NEEDLE) OF THE SUTURE NEEDLES WERE SEWN ON TO THE SURGICAL TECH¿S STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177277 ENDO STITCH 10MM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN J8K0191EX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR