BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 3516520 · Received November 11, 2013

    Report

    Report Number
    3516520
    Event Type
    Malfunction
    Date Received
    November 11, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SCRUB TECH HAD DIFFICULTY UNLOADING THE ENDO NEEDLE. THE RELEASE BUTTON WOULD NOT MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580632 ENDO STITCH SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE KOG COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR