BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING LOOP

    MDR report key: 3839287 · Received May 20, 2014

    Report

    Report Number
    2951238-2014-00208
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    HIN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. IF ADD'L INFO IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A HYSTEROSCOPY PROCEDURE A PIECE OF THE DEVICE BROKE OFF INSIDE THE PT. THE PT CAVITY AND TISSUE WAS SEARCHED. HOWEVER, NOTHING WAS FOUND. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299141 CUTTING LOOP LOOP HIN GYRUS ACMI INC. MLE-24-012 111153GB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other