BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED MARYLAND DISSECTOR - REUSABLE

    MDR report key: 1743130 · Received June 29, 2010

    Report

    Report Number
    1722040-2010-00004
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HOUSING AND JAWS DISCONNECTED FROM INSERT ROD DUE TO METAL FATIGUE AT CONNECTION POINT. DEVICE HAD BEEN IN USE OVER 7 YEARS.

    Description of Event or Problem · 1

    HOSPITAL REPORTED GRASPER HEAD DISCONNECTED FROM SHAFT - COULD HAVE FALLEN INTO PATIENT. LAP CHOLE PROCEDURE. PATIENT OUTCOME UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED MARYLAND DISSECTOR - REUSABLE LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES0501 HK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR