BEUDAMED
    FDA Adverse Event Other Summary report: N

    5MM AEM HANDLE ASSEMBLY

    MDR report key: 448203 · Received March 12, 2003

    Report

    Report Number
    1722040-2003-00003
    Event Type
    Other
    Date Received
    March 12, 2003
    Date of Event
    February 25, 2003
    Report Date
    March 7, 2003
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED CAUTERIZED TISSUE APPROX. 1" FROM DISTAL END. HOWEVER, NO SERIOUS PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM AEM HANDLE ASSEMBLY LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION INC. ES5700S FL

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention