BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USA SERIES OPERATIVE HYSTEROSCOPE SHEATH

    MDR report key: 2837644 · Received November 8, 2012

    Report

    Report Number
    1519132-2012-00039
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CANNOT CONFIRM CUSTOMERS STATED PROBLEM. THE UNITS FUNCTIONED AS INTENDED. NO MISSING MATERIAL WAS FOUND, THE DISTAL END OF THE TUBE HAS NORMAL WEAR OF DING AND DENTS. THE TUBE HAS MULTIPLE SCRATCHES, ALL COSMETIC.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, METAL FLAKES FELL OFF INTO THE PT. THE FLAKES WERE RETRIEVED BY THE SURGEON WITHOUT ANY INJURY TO THE PT. ALL DEVICES USED WERE ALSO REPLACED TO FINISH THE PROCEDURE WHICH WAS EXTENDED ABOUT 1/2 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA SERIES OPERATIVE HYSTEROSCOPE SHEATH OPERATIVE HYSTEROSCOPE SHEATH HIH GYRUS ACMI, INC. GYO-6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK