BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA ELITE SYSTEM IGLESIAS WORKING ELEMENT

    MDR report key: 146234 · Received January 28, 1998

    Report

    Report Number
    1519132-1998-00001
    Event Type
    Malfunction
    Date Received
    January 28, 1998
    Date of Event
    December 9, 1997
    Manufacturer
    CIRCON ACMI
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY INSTRUMENT INVOLVED WAS GEIS-HCF25 INNER SHEATH, NOT THE EIWE WORKING ELEMENT AS INITIALLY REPORTED.

    Description of Event or Problem · 1

    ARCING AND BURNING REPORTED DURING HYSTEROSTOMY PROCEDURE; PT SUSTAINED LARGE BURN ON INNER WALL OF UTERUS. RESECTOSCOPE INNER SHEATH TIP ALSO REPORTEDLY SEPARATED IN VIVO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE SYSTEM IGLESIAS WORKING ELEMENT WORKING ELEMENT FED CIRCON ACMI GEIS-HCF25 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO CAT. NO. GEIS-HCF25| CIRCON ACMI USA ELITE CONTINUOUS FLOW INNER SHEATH