BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED MARYLAND DISSECTOR - REUSABLE INSERT

    MDR report key: 537429 · Received March 22, 2004

    Report

    Report Number
    1722040-2004-00003
    Event Type
    Malfunction
    Date Received
    March 22, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 22, 2004
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP STERILIE PROCESSING PRESONNEL REPORTED THE HOUSING AND GRASPER JAWS CAME OFF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND THE MFR HAS BEEN UNABLE TO FIND OUT IF THIS HAPPENED DURING A SURGICAL PROCEDURE. IF SO, THERE MAY HAVE BEEN A DELAY TO RETREIVE THE PARTS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED MARYLAND DISSECTOR - REUSABLE INSERT LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION INC. ES0526 IC

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other